GMP Audit Checklist-2020

SIZA INTERNATIONAL (PVT) LTD.
18 Km Ferozepur Road Lahore-Pakistan

STANDARD OPERATING PROCEDURE
Department: QUALITY ASSURANCE
TITLE: AUDIT NON-CONFIRMITY FORM
Form No. Superseded Doc. Ref. No. Page No.
QAD-DOC-001.F24.01 FQA-018-00 QAD-SOP-DOC-007.01 1 of 24
Review Date Issue Date Effective Date Next Review Date
07 JUN 2023
MANUFACTURING PRACTICE AUDIT

(GMP AUDIT – CHECK LIST)
Part 1:
1.1 General Information about Unit
Date of inspection
Purpose of inspection
Name of inspector (s)

Name: Mr. Muhammad Imran
Title: Production Manager
Signature: __________________
Name: Mr. Riasat Ali

Title: Quality Control Manager
Signature: __________________
Name: Mr. Salauddin

Title: Engineering Manager
Signature: ______________________
Name: Mr. Hassan Nazir

Title: QA Executive
Signature: ______________________
Name: Mr. Muhammad Irfan Ahmad

Title: Ware House Incharge
Signature: __________________
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1.4 Brief History of previous inspections:
1.5 Focus of the inspection :

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Good Manufacturing Practice – GMP Audit Checklist

Sr. # (Contents) Page #
1.0 QUALITY ASSURANCE 4
2.0 PREMESIS 4
3.0 PERSONNEL (STAFFING PLAN, STAFF QUALIFICATION, EXPERIENCE , ON THE JOB
TRAINING & HYGIENE) 5
4.0 VALIDATION 5
5.0 DOCUMENTATION / RECORDS 6
6.0 VENDOR QUALIFICATION 7
7.0 CHANGE CONTROL PROGRAM 7
8.0 SAMPLE 7
9.0 STABILITY STUDIES 7
10.0 DRUG RECALL 8
11.0 ANNUAL PRODUCT REVIEW 8
12.0 AUDIT / COMPLAINTS 8
13.0 QUALITY CONTROL DEPARTMENT 8
14.0 MANUFACTURING AREA 9
15.0 MANUFACTURE OF STERILE PRODUCTS 10
16.0 MANUFACTURING (ORAL DOSAGE FORM) 18
17.0 PACKAGING 19
18.0 REPROCESSING 19
19.0 FINISHED PRODUCT CONTROL 19
20.0 WAREHOUSING / DISTRIBUTION 19
21.0 ENVIRONMENT, HEALTH & SAFETY 20
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GOOD MANUFACTURING PRACTICE

(GMP AUDIT- CHECK LIST)
SR # CRITERIAS Yes or No REMARKS
1.0 QUALITY ASSURANCE
1.1 Does the company have mission statement and the quality
policy?
1.2 Is the company ISO certified?
1.3 Was the company previously audited (GMP audit)?
1.4 Are pharmaceutical products designed and developed
according to the requirement of GMP & other associated
codes such as good laboratory practice (GLP) and good
clinical practice (GCP)?
1.5 Are production and control operations clearly specified in a
written form and GMP requirements are adopted?
1.6 Are managerial responsibilities clearly specified in job
descriptions?
1.7 Are all necessary controls on starting materials,
intermediate products and other in-process controls,
calibrations and validation carried out?
1.8 Are finished products correctly processed and checked
according to the defined procedures?
1.9 Are satisfactory arrangements existed to store in
appropriate storage conditions?
2.0 PREMESIS
2.1 (DESIGN & LAYOUT OF FACILITIES)
Does the facility have proper design, layout and finishes
based on contemporary standards to:
2.1.1 Manufacture high quality medicine.
2.1.2 Avoidance of cross contamination.
2.1.3 Proper cleaning, drainage and sanitizing.
2.1.4 Ventilation, air conditioning and maintenance.
2.2 Is there emergency power supply available to take care of
entire energy demand or at least critical areas?
2.3 Does the facility have appropriate controls to maintain
required parameters e.g. temperature, relative humidity and
pressure differentials etc?
2.4 Are the doors, windows, walls, ceiling and floor such that
no holes or cracks evident (other than those intended by
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design)?
2.5 PLANT SAFETY & SECURITY
2.5.1 Does the facility have safety program?
2.5.2 Are safety procedures written?
2.5.3 Do employees receive safety orientation before working in
the plant area?
2.5.4 Does the facility have a formal, written security policy?
2.5.5 Is access to the facility restricted?

2.6 SANITATION
2.6.1 Is written sanitation program available on the premises?
2.6.2 Is sanitation program is implemented and effective in

preventing conditions?
3.0 PERSONNEL (STAFFING PLAN, STAFF QUALIFICATION, EXPERIENCE , ON THE JOB
TRAINING & HYGIENE)
3.1 Has the facility provided sufficient qualified personnel to
fulfill all its responsibilities required under the rule?
3.2 Has the facility provided Organization Chart?

3.3 Does the company have qualified, trained and experience
staff required for managing?
3.4 Does the company have “On the job training program” for
technical staff?
3.5 Is the technical staff, including supervisors and operations
certified (and documented) in specialized training e.g.
aseptic technique, sterilizing, washing, depyrogenation,
visual inspection, standard operating procedure etc.
3.6 HYGIENE
3.6.1 Are all the personal under gone health examination to prior
to employment?
3.6.2 Are all the personnel provided health examination during
employment?
3.6.3 Are workers conducting visual inspections under gone
periodic eye examination?
3.6.4 Are the record maintained?
3.6.5 Are all personal aware about of the principles of GMP and
received initial and continued training including hygiene
instructions
4.0 VALIDATION
4.1 Is validation properly documented and include Validation
Master Plan, Validation Protocols, Validation Reports and
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Equipment Qualified?
4.2 Are validation studies conducted in accordance with pre-
defined protocols?
4.3 Have production procedures been validated?
4.4 Does the process control address an issue to ensure identity,
strength, quality and purity of product?
4.5 Does the procedure include formulation that is written to
yield not less than 100% of established amount of active
ingredients?
4.6 Are all weighing and measuring performed by one qualified
person and observed by a second person and is dully signed
by both of them on record sheet?
4.7 Validation of New Master Formula:
Is new master formula or method of preparation adopted
and steps taken to demonstrate its suitability for routine
processing, process defined materials and equipment
specified?
4.8 Validation of Equipment & Materials:
Are significant amendments to the manufacturing process,
including any change in equipment and materials affecting
product quality or re-productivity of process validated?
4.9 Are validation records properly maintained?
5.0 DOCUMENTATION / RECORDS
5.1 Are documentation meticulously maintained as per rules
and regularly reviewed and kept up to date?
5.2 Is documentation accurate, clear & neat. Does it define
specifications and procedures for all materials & methods
of manufacture & control?,
5.3 Are all the specifications, testing procedures master
formulae, packing instructions and standard operating
procedures (SOPs) available, current & being followed?
5.4 Do the records provide existence of documented evidence,
traceability, and an audit trial that will permit
investigation?
5.5 Does the record provide batch processing & packaging
details including receiving sample, processing equipment,
analytical testing and laboratory instrument records?
5.6 LABELS
5.6.1 Are labels to the containers, equipment or premises applied
un-ambiguously according to company’s agreed format?
5.6.2 Are labels of different colors indicating the status such as
“Quarantined”, “Accepted”, “Rejected”, or “Clear” used?
5.6.3 Are all finished products are labeled as per specification?
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5.6.4 PROCESS DOCUMENTS / RECORDS

 Are following documents / record are available:
5.6.4.1 Starting material re-assy.
5.6.4.2 Specifications for intermediate and bulk products
5.6.4.3 Batch processing records
5.6.4.4 Record for process operation
5.6.4.5 Batch packaging records
5.6.4.6 Record for packaging operation
5.6.4.7 Record of Batch numbers
5.6.4.8 Analytical records of the batch
5.6.4.9 Record for finished product release procedure
5.6.5 STANDARD OPERATING PROCEDURES (SOPS)
 Are SOPS and associated records of actions, conclusions
reached available for the following at the premises?
5.6.5.1 Equipment assembly and validation
5.6.5.2 Analytical apparatus and calibration
5.6.5.3 Maintenance, cleaning and sanitization
5.6.5.4 Personnel matters including qualification, training, clothing
and hygiene
5.6.5.5 Environmental monitoring
5.6.5.6 Pest control
5.6.5.7 Complaints
5.6.5.8 Drug recalls
5.6.5.9 Drug returns
5.7 EQUIPMENT LOG BOOKS
5.7.1 Are log books for major & critical equipments identified by
company kept?
6.0 VENDOR QUALIFICATION
6.1 Do you have list of approved vendors?
6.2 Are the vendors supplying raw material (both active &
inactive ingredients), empty gelatin capsules, primary
packaging & printed packaging components audited &
found to be satisfactory?
7.0 CHANGE CONTROL PROGRAM
7.1 Is there a formal change control program in place
supported by an SOP to initiate, review & approve changes
in material, sources, processes, products packaging,
equipment, batch size changes etc.
8.0 SAMPLE
8.1 Does the company retain a sample of lot or batch of the
packaged / labeled drug for a period of at least one year
after the expiration date on the label of the drug?
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8.2 Does the company retain a sample of each lot or batch of a

raw material (including both active and inactive
ingredients)?
9.0 STABILITY STUDIES
9.1 Does the company have a prospective and concurrent
stability studies program based on SOP and utilizing proper
equipment i.e. climatic chambers maintained at 30° C /
65% RH for ambient and 40° C / 75% RH for stress
conditions and continuously monitored for temperature &
RH?
9.2 Is stability of finished products evaluated and documented
prior to marketing?
9.3 Does the stability data support shelf life assigned to the
product. Are any deviations in data reviewed and
appropriate steps taken in case of stability issues?
10.0 DRUG RECALL
10.1 Do you have SOP for drug recalls?
10.2 If answer yes to the above did you have any drug recall in
the past 2 year? (Please also mention the name of products)
11.0 ANNUAL PRODUCT REVIEW
11.1 Is there a process in place to review statistical data (i.e.:
trend analysis, reworks, rejects, customer complaints) of all
the products manufacture during the year?
11.2 Provide name of the products manufactured by you along
with price list.
11.3 Provide the source of raw material for individual products.
11.4 Do you export your products, if so then to whom and
mention the name of the products?
12.0 AUDIT / COMPLAINTS
12.1 INTERNAL GMP AUDITS
12.1.1 Do you have an effective internal GMP inspection program
to audit all the manufacturing areas, activities & QC lab at
specific defined periods?
12.1.2 Is there a process in place to fill the gaps / observation /
non-conformance found during the internal GMP audits?
12.2 QUALITY AUDITS
Is quality audit conducted by outside or independent
specials or a team designated by the management for the
purpose?
12.3 COMPLAINTS
Are complaints and other information concerning
potentially defective products carefully reviewed according
to the written procedures?
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13.0 QUALITY CONTROL DEPARTMENT

13.1 Does the QC lab have SOPs to cover all the functional
areas?
13.2 Are adequate facilities and equipments available for the
physical, chemical & microbiological testing?
13.3 Are approved written procedures available for sampling,
inspecting and testing raw materials, packaging materials,
in process drugs, bulk drugs and finished products?
13.4 Are samples of starting material, packaging material,
intermediate products, bulk products and finished products
taken by methods and personnels approved by QC
department?
13.5 Are in-process materials tested at appropriate phases for
identity, strength, quality, purity and are they approved or
rejected by Quality Control?
13.6 Are records of in- process controls maintained?
13.7 Does each batch of drug product prior to release confirms
compliance of finished product specification?
13.8 Are validated & stability indicating assay methods used?
13.9 Are reference standards used for the assay?
13.10 Are accurate, clear & neat records maintained along with
the raw data for the entire analytical work?
14.0 MANUFACTURING AREA
14.1 EQUIPMENTS, MATERIAL / COMPONENT
EQUIPMENTS
14.1.1 Does the company have suitable equipments capable of
producing consistent quality products?
14.1.2 Do the equipments meet contemporary standards for the
manufacture of pharmaceuticals i.e. smooth finishes, right
quality construction material for the intended purpose, easy
to clean, wash, sterilize etc.
14.1.3 Are the following pieces of equipments suitable in their
design/size & capacity? (Blendes, Conveyors, Tablet
presses, Capsule fillers, Bottle fillers etc)
14.1.4 Does the equipments & facilities have appropriate controls
to maintain required parameters e.g. temperature, relative
humidity, pressure differentials etc?
14.1.5 Is the equipment cleaned promptly after use?
14.1.6 EQUIPMENT/INSTRUMENTS CALIBRATION &
PREVENTIVE MAINTENANCE
14.1.6.1 Are written records maintained on equipment cleaning,
sanitizing and maintenance on or near each piece of
equipment?
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14.1.6.2 Does the facility have approved written procedures for

checking and calibration of each piece of measurement
equipment?
14.1.6.3 Are records of calibration checks and inspections
maintained in a readily retire able manner?
14.1.7 MATERIAL/COMPONENT
14.1.7.1 All handling of material and products such as receipt,
quarantine, sample storage, tracking, labeling, dispensing,
processing, packaging and distribution is done in
accordance with approved written procedure, or instruction
and recorded?
14.1.7.2 All incoming materials and finished products quarantined
immediately after receipt or processing until they released
for use or distribution?
14.1.7.3 Are all materials handled in such a way to prevent
contamination?
14.2 RAW MATERIAL
14.2.1 Were the premises designed for storing the raw material?
14.2.2 Does the store premises allow storage of raw materials at
various temperatures?
14.2.3 If answer yes to the above what are the controls to log any
irregularities?
14.2.4 What is the source of the active ingredient used?
14.2.5 What are the source of additives used?
14.2.6 Is any documentation done at the time of receiving the raw
materials?
14.2.7 What is the process of communication with the laboratory
for sampling of the raw material?
14.2.8 Is there a quarantine for storing unreleased raw materials?
14.2.9 If so, what is the process?
14.2.10 What is the process of storage after the raw material is
released for use?
14.2.11 What is the process of issue of raw material for
manufacturing?
14.2.12 Who is responsible of issuing?
14.2.13 What is the process of revalidation of balances?
14.2.14 What is the process of revalidation of raw materials?
14.2.15 Do you have a standard operational procedural manual for
stores?
15.0 MANUFACTURE OF STERILE PRODUCTS
15.1 General
15.1.1 The production of sterile preparations shall be carried out
in clean areas, entry to which shall be through airlocks for
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personnel and/or for goods. Clean areas shall be maintained

to an appropriate standard of cleanliness and supplied with
air that has passed through filters of an appropriate
efficiency.
15.1.2 The various operations of component preparation (such as
containers and closures) product preparation, filling, and
sterilization shall be carried out in separate areas within the
clean area
15.1.3 Clean areas for the production of sterile products are
classified according to the required characteristics of the
air, in grades A, B, C and D
15.1.4 Area Grade. -- Area grades must be selected by the
manufacturer on the basis of validation runs (e.g. sterile
media fills.
15.2 Manufacture of sterile preparations
15.2.1 Manufacturing Operations Classifications are here divided
into three categories:
(a) Terminally sterilized product.-- Those in which the
preparation is sealed in its final container and terminally
sterilized;
(b) Products sterilized by filtration.-- The preparation is
sterilized by filtration;?
(c) Products manufactured under aseptic conditions.--
Those in which the preparation can be sterilized neither by
filtration nor terminally and consequently must be
produced from sterile starting materials in an aseptic way
15.2.2 Terminally sterilized products.-- Solutions shall generally
be prepared in a grade C environment in order to give how
microbial and particulate counts, suitable for immediate
filtration and sterilization. Solution preparation could be
allowed in a grade D environment if additional measures
are taken to minimize contamination, such as the use of
closed vessels. For parenteral, filing shall be done in a
laminar-airflow workstation (grade A) in a grade C
environment. The preparation of other sterile products, e.g.,
ointments, creams, suspensions and emulsions, and filling
of containers shall generally be done in a grade C
environment before terminal sterilization
15.2.3 Products sterilized by filtration.-- The handling of starting
materials and the preparation of solutions shall be done in a
grade C environment. These activities could be allowed in a
grade D environment if additional measures are taken to
minimize contamination, such as the use of closed vessels
prior to filtration. After sterile filtration, the product must
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be handled and dispensed into containers under aseptic

conditions in a grade A or B area with a grade B or C
background, respectively.
15.3 Personnel
15.3.1 General.-- Only the minimum number of personnel
required shall be present in clean areas, and it is
particularly, important during aseptic processes.
Inspections and control shall be conducted from outside the
areas as far as possible
15.3.2 Personnel training.-- All personnel, including those
concerned with cleaning and maintenance, employed in
such areas shall receive regular training for disciplines
relevant to the correct manufacture of sterile products,
including reference to hygiene and to the basic elements of
microbiology. When outside staff who have not received
such training (e.g. building or maintenance contractors),
need to be brought in, particular care shall be taken over
their supervision.
15.3.3 Entry restricted.-- Staff who have been engaged in the
processing of animal tissue materials or of cultures of
microorganisms other than those used in the current
manufacturing process shall not enter sterile-product areas
unless rigorous and clearly defined decontamination
procedures have been followed
15.3.4 Hygiene and cleanliness.-- High standards of personal
hygiene and cleanliness are essential and personnel
involved in the manufacture of sterile preparations shall be
instructed to report apparent illness or open lesion. Periodic
health checks for such conditions are desirable, and actions
to be taken about personnel who could be introducing
undue microbiological hazard shall be decided by a
designated competent person.
15.3.5 Use of protective garments.-- Outdoor clothing shall not be
brought into the clean areas, personnel entering the
changing rooms shall already be clad in standard factory
protective garments and changing and washing shall follow
a written procedure
15.3.6 Clothing requirements.-- The clothing and its quality shall
be appropriate for the process in such a way so as to protect
the product from contamination
15.3.7 Protective garments in grade B room.-- For every worker in
a grade B room, clean sterilized protective garments shall
be provided at each work session, or at least once a day if
monitoring results justify it, the gloves shall be regularly
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dis-infected during operations, masks and gloves shall be

changed at least at every working session, and the use of
disposable clothing may be followed when possible
15.3.8 Washing of clothing.-- Clothing used in clean areas shall be
washed or cleaned in such a way that it does not gather
additional particulate contaminants that can later be shed.
Separate laundry facilities for such clothing are desirable. If
fibers are damaged by inappropriate cleaning or
sterilization there may be an increased risk of shedding
particles. Washing and sterilization operations shall follow
standard operating procedures
15.3.8 Prohibitions.-- Wrist-watches and jewellery shall not be
worn in clean areas, and cosmetics that can shed particles
shall not be used, clothing shall be appropriate to the air
grade of the area where the personnel will be working, and
the description of clothing required for each grade is given
below:
Grade D: -- The hair and, where appropriate, beard shall be
covered, protective clothing and appropriate shoes or long
shoes shall be worn, and appropriate measures shall be
taken to avoid any contamination coming from outside the
clean area.
Grade C: -- The hair and, where appropriate, beard shall be
covered, a single or two-piece trouser suit, gathered at the
wrists and with a high neck and appropriate shoes or
overshoes, shall be worn, and the clothing shall shed
virtually no fibers or particulate matter
Grade B:-- Headgear shall totally enclose the hair and
where appropriate, beard; it shall be tucked into the neck of
the suit, a face mask shall be worn to prevent the shedding
of droplets’ sterilized non-powdered rubber or plastic
gloves and sterilized or disinfected footwear shall be worn;
trouser-bottoms shall be tucked inside the footwear and
garment sleeves into the gloves, and the protective clothing
shall shed virtually no fibers or particulate matter and shall
retain particles shed by the body.
15.4 Maintenance of clean area
15.4.1 General.-- Each manufacturing operation requires an
appropriate air cleanliness level in order to minimize the
risks of particulate or microbial contamination of the
product or materials being handled.
15.4.2 Air supply system.-- A filtered air supply system of
appropriate efficiency, shall maintain a positive pressure
relative to surrounding area under all operational conditions
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and flush the area effectively. Moreover particular attention

shall be paid to the protection of the zone of greatest risk
that is, the immediate environment to which the product
and the cleaned components in contact with it are exposed,
and the various recommendations regarding air supplies
and pressure differentials may need to be modified if it
becomes necessary to contain materials such as pathogenic,
highly toxic, radioactive, or live viral or bacterial materials.
Decontamination facilities and the treatment of air leaving
a clean area may be necessary for some operations
15.4.3 Water supply.-- Water treatment plant shall not be operated
beyond their designed capacity and water shall be
produced, stored and distributed in a manner that prevents
microbial growth for example by constant circulation at
90C or at temperature validated to keep microbial count of
water within the limit.
15.4.4 Documentation.-- All equipment, including sterilizers, air-
filtration systems, and water-treatment systems including
still, shall be subject to planned maintenance, validation
and monitoring, and its approved use, following
maintenance work, shall be documented.
15.4.5 Airlock system. -- The entry to the sterile production areas
shall be through airlocks for personal and/or for materials.
Airlocks doors shall not be opened simultaneously, and an
interlocking system and a visual and/or audible warning
system where appropriate shall be operated to prevent the
opening of more than one door at a time
15.4.6 Maintenance of equipment. -- When equipment
maintenance is carried out within the clean area, clean
instruments and tools shall be used, and the area shall be
cleaned and dis-infected, where appropriate, before
processing recommences if the required standards of
cleanliness and/or asepsis have not been maintained during
the maintenance work.
15.5 Procedure
15.5.1 Procedure.-- The sanitation of clean areas is particularly
important, they shall be cleaned frequently and thoroughly
in accordance with a written progress approved by the
quality control department, where disinfectants are used,
more than one type shall be employed with periodic
alterations, the monitoring shall be regularly undertaken in
order to detect the emergence of resistant strains of
microorganisms, and in view of its limited effectiveness,
ultraviolet light shall not be used as a substitute for
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chemical disinfection.
15.5.2 Use of disinfectants and detergents.-- Disinfectants and
detergents shall be monitored for microbial contamination.
Dilutions shall be kept in previously cleaned containers and
shall not be stored for long periods unless sterilized, and
partly emptied containers shall not be topped up.
15.5.3 Fumigation. -- Fumigation of clean areas may be useful
reducing microbiological contamination in inaccessible
places, if required.
15.5.4 Monitoring of clean areas.-- Clean areas shall be monitored
at planned intervals during operations by means of
microbial counts of air and surfaces, where aseptic
operations are performed, monitoring shall be frequent to
ensure that the environment is within specifications, the
results of monitoring shall be considered when batches are
assessed for approval, air particulate quality shall also be
evaluated on a regular basis, and additional monitoring is
sometimes desirable even when there are no production
operations such as after validation of systems, cleaning and
fumigation.
15.6 Processing
15.6.1 Precautions against contamination.-- Precautions to
minimize contamination shall be taken during all
processing stages including the stages before sterilization.
15.6.2 Preparations of live organisms.-- Preparations containing
live microbiological organisms shall not be made or
containers filled in areas used for the processing of other
pharmaceutical products except for validation purposes,
however, vaccines of dead organisms or of bacterial
extracts may be dispensed into containers after validated
inactivation and validated cleaning procedures in the same
premises as other sterile pharmaceutical products.
15.6.3 Simulation of aseptic operations validation.-- The use of
nutrient media that support microbial growth in trials to
simulate aseptic operations, sterile media fills and broth
fills, is a valuable part of overall validation of an aseptic
process, and such trials shall have the following
characteristics, namely:
(a) they shall simulate as closely as possible actual
operations, taking into account such factors as complexity
of operations, number of personnel working, and length of
time;
b) the medium or media selected shall be capable of
growing a wide-spectrum of microorganisms, including
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those that would be expected to be found in the filling

environment; and (c) they shall include a sufficient number
of units of production to give a high degree of assurance
that low levels of contamination, if present would be
detected.
15.6.4 Monitoring water supply sources. -- Water sources, water-
treatment equipment and treated water shall be monitored
regularly for chemicals, biological contamination and
contamination with endotoxins to ensure that the water
complies with the specifications appropriate to its use.
records shall be maintained of the results of the monitoring
and of any action
15.6.5 Activities in clean areas kept minimum -- Activities in
clean areas, especially when aseptic operations are in
progress, shall be kept to a minimum and the movement of
personnel shall be controlled and methodical to avoid
excessive shedding of particles and organisms due to over-
vigorous activity, and the ambient temperature and
humidity shall, not be uncomfortably high because of the
nature of the garments worn.
15.6.6 Care of staring materials.-- Micro-biological contamination
(bioburden) of starting materials shall be minimal which
shall be monitored before sterilizations, and specifications
shall include requirements for microbiological quality when
the need for this has been indicated by monitoring.
15.7 Sterilization
15.7.1 General.-- Sterilization can be achieved by moist or dry
heat, sterilizing agent, by filtration with subsequent aseptic
filing of sterile final containers, or by irradiation with
ionizing radiation but not with ultraviolet radiation unless
the process is thoroughly validated each method has its
particular applications and limitations, and where possible
and practicable heat sterilization is the method of choice.
15.7.2 Validation.-- All sterilization processes must be validated
and particular attention shall be given when the adopted
sterilization method is not in accordance with
prarmacopoeial or other national standards or when it is
used for a preparation that is not a simple aqueous or oily
solution.
15.7.3 Suitability of process.-- Before any sterilization process is
adopted, its suitability for the product and its efficacy in
achieving the desired sterilization conditions in all parts of
each type of load to be processed shall be demonstrated and
this work shall be repeated at scheduled intervals, at least
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annually, and whenever significant modifications have

been made to the equipment, and records shall be kept of
the results.
15.7.4 Care for biological indicators.-- Biological indicators shall
be considered only as an additional method for monitoring
the sterilization, and if they are used, strict precautions
shall be taken to avoid transferring microbial
contaminations from them
15.8 Sterilization by heat
15.8.1 Recording sterilization cycle.-- Each heat sterilization cycle
shall be recorded by appropriate equipment with suitable
accuracy and precision such as time and temperature chart
with a suitably large scale, the temperature shall be
recorded from a probe at the coolest part of the load or
loaded chamber having been determined during the
validation. The temperature shall preferably, be checked
against a second independent temperature probe located at
the same position, the chart, or a photocopy of it, shall form
part of the batch record, and chemical or biological
indicators may also be used but shall not take the place of
physical controls.
15.8.2 Sufficient time allowed to reach required temperature.--
Sufficient time must be allowed for the whole of the load to
reach the required temperature before measurement of the
sterilizing time is started and this time must be determined
for each type of load to be processed.
15.8.3 Precautions during cooling.-- After the high-temperature
phase of a heat sterilization cycle, precautions shall be
taken against contamination of a sterilized load during
cooling, and any cooling fluid or gas in contact with the
product shall be sterilizer, unless it can be shown that any
leaking container would not be approved for use.
15.9 Sterilization by moist heat
15.9.1 General.-- Sterilization by moist heat is suitable only for
water-wettable materials and aqueous solutions, both
temperature and pressure shall be used to monitor the
process, the temperature recorder shall normally be
independent of the temperature regulator and there shall be
an independent temperature indicator, the reading from
which is routinely checked against the chart recorder during
the sterilization period, for sterilizers fitted with a drain at
the bottom of the chamber, it may also be necessary to
record the temperature at this position, throughout the
sterilization period, and there shall be regular leak test on
07 JUN 2023
the chamber when a vacuum phase is part of the cycle.

15.9.2 Wrapping materials.-- The items to be sterilized, other than
products in sealed containers, shall be wrapped in a
material that allows removal of air and penetration of steam
but prevents recontamination after sterilization and all parts
of the load shall be in contact with water or saturated steam
at the required temperature for the required time.
15.9.3 Care shall be taken to ensure that steam used for
sterilization is of suitable quality and does not contain
additives at a level that could cause contamination of the
product or equipment.
15.10 Sterilization by dry heat
15.10.1 The process used for sterilization by dry heat shall include
air circulation within the chamber and the maintenance of a
positive pressure to prevent the entry of non-sterile air, if
air is supplied, it shall be passed through a microorganism-
retaining filter, and where this process of sterilization by
dry heat is also intended to remove pyogens, challenge tests
using endotoxins would be required as part of the
validation.
15.11 Quality control testing
15.11.1 Sterility testing.-- Samples taken for sterility testing shall
be representative of the whole of the batch but shall, in
particular, include samples taken from parts of the batch
considered to be most at risk of contamination, such as:--
(a) for products that have been filled aseptically, samples
shall include containers filled at the beginning and end of
the batch and after any significant interruption of work; and
(b) for products that have been heat sterilized in their final
containers, and samples can be taken from any part of the
load.
15.11.2 Sterility test as the last measures.-- The sterility test applied
to the finished product shall be regarded only as the last in
a series of control measures by which sterility is assured
and can be interpreted only in conjunction with the
environmental and batch processing records.
15.11.3 Monitoring endotoxins.-- For injectable products,
consideration shall be given to monitoring the water and
the intermediate and finished product for endotoxins, using
an established pharmacopoeial method that has been
validated for each type of product, for large-volume
infusion solutions, such monitoring of water or
intermediates shall always be done, in addition to any tests
required by the marketing authorization on the finished
07 JUN 2023
product, and when a sample fails a test, the cause of failure

shall be investigated and remedial action taken where
necessary.
16.0 MANUFACTURING (ORAL DOSAGE FORM)
16.1 What is the receiving process of raw material from the
stores?
16.2 Where is the raw material stored after being issued from the
stores?
16.3 Does the QC validate the water used during the
manufacturing process?
16.4 What is the source of water?
16.5 What are the SOP for the dryers used?
16.6 What are the controls for the temperature logging of the
dryers?
16.7 What are SOP to eradicate cross contamination?
16.8 What procedures are adopted for storing of granules
checked by QC for releasing the batch for compression?
16.9 Are the granules checked by QC for releasing the batch for
compression?
16.10 During compression what are the SOP followed?
16.11 How frequent does QC inspector verifies the compression
process?
16.12 How many compression machines are handled by one
operator?
16.13 If answer to above is more than one what precautions are in
force to avoid cross contamination between different
products?
16.14 How are the compressed tablets stored before the batch is
released for packaging?
16.15 Are there temperature log sheets maintain during the
manufacturing cycle?
16.16 What safety measures are adopted for the personnel
working in manufacturing?
16.17 Do you manufacture capsule dosage form
16.18 What types of humidifiers are used at the point of capsule
filling?
16.19 Is filling done on an automatic, semi-automatic or manual
machine?
16.20 How is the polishing of filled capsules done?
16.21 What are the SOP for liquid manufacturing?
16.22 What is the process of bottle washing?
16.23 What is the type of water used in bottle washing?
16.24 How is the batch released by QC?
07 JUN 2023
16.25 How are the stainless steel tanks washed after completion
of a product?
16.26 Check on yields and reconciliation of quantities are carried
out at appropriate stages of the process to ensure that yields
are within acceptable limits.
16.27 Are the deviations from the expected yield are recorded and
investigated?
17.0 PACKAGING
17.1 What is the glass type of the bottles used?
17.2 What are SOP for
a. Packaging Materials
b. Packaging Operation
c. Labels and Labeling
17.3 How frequent does the QC inspector visits the packaging
area?
17.4 Is the integrity of the batch maintained during the
packaging process?
17.5 Is there SOP for packaging Material?
17.6 Is there SOP for Packaging Operations?
17.7 Is there SOP for Labels & Labeling?
17.8 All products and packaging materials to be used are
checked on receipt by the packaging department for
quality, identity and conformity with the packaging
instructions?
17.9 The name and batch number of the product being handled
is displayed at each packaging station or line?
18.0 REPROCESSING
18.1 Do written procedures identify steps for reprocessing
batches?
18.2 Does QC testing confirms that reprocessed batches
conforms to established specification?
19.0 FINISHED PRODUCT CONTROL
19.1 Do written procedures indicate how and who verifies that
correct containers and packages are used for finished
product during their finishing operation?
19.2 Has the formulation of each product been tested for
stability based on a written protocol?
19.3 Are written sampling and testing procedures and
acceptance criteria available for each product to ensure
conformance to finished product specification?
20.0 WAREHOUSING / DISTRIBUTION
20.1 Are material stored under conditions as per the storage
instructions on the label?
07 JUN 2023
20.2 Is there adequate space for the orderly storage of material?

20.3 Is there a segregation of quarantined, approved & rejected
materials?
20.4 Are there separate stores for raw material, packaging
material, labels and finished products?
20.5 Are materials stored on pallets, shelves, or racks, off the
floor and off the walls in all stores?
20.6 Are minimum and maximum temperatures in the store
recorded?
20.7 Are air-conditioned and cold room facilities available?
20.8 Are flammable and hazardous chemicals stored in safe
conditions?
20.9 Are there no expired raw materials in the raw material
store(s)?
20.10 Are materials dispensed according to prescribed SOP
meeting GMP requirements?
20.11 After release by quality control, are raw materials and
packaging materials released on a FIFO (first in first out)
basis?
20.12 Do distribution records in the finished goods store enable
specific batches to be traced?
21.0 ENVIRONMENT, HEALTH & SAFETY
21.1 Does the company monitor and maintain incident / accident
data etc to create awareness and develop improvement
plans?
21.2. Does the company industrial hygiene sampling /
monitoring program, do the employees use appropriate
personnel protective equipment?
21.3 Does the company have fire fighting facility having fire
hydrants, sprinkler system & trained people to handle the
emergency?
21.4 Does the company have a proper hazardous and non-
hazardous material storage and disposal system? (e.g.
explosion proof cabinets & manufacturing suites,
flammable storage area, solid waste incineration and waste
water treatment)?
21.5 Are drains and routine cleaning procedures sufficient to
prevent standing water inside the facility?
21.6 Is lighting adequate in all areas?
21.7 Is the control of air pressure, dust humidity and temperature
adequate for the manufacturing, processing storage or
testing of the drug products?
21.8 If air filters are used is there a written procedure specifying
07 JUN 2023
the frequencies of inspection and replacement?

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SIZA INTERNATIONAL (PVT) LTD.

18 Km Ferozepur Road Lahore-Pakistan

MANUFACTURING PRACTICE AUDIT

1.1 General Information about Unit

Name of inspector (s)

Name: Mr. Riasat Ali

Name: Mr. Salauddin

Name: Mr. Hassan Nazir

Name: Mr. Muhammad Irfan Ahmad

1.4 Brief History of previous inspections:

1.5 Focus of the inspection :

Good Manufacturing Practice – GMP Audit Checklist

GOOD MANUFACTURING PRACTICE

2.5.5 Is access to the facility restricted?

2.6.2 Is sanitation program is implemented and effective in

3.2 Has the facility provided Organization Chart?

5.6.4 PROCESS DOCUMENTS / RECORDS

8.2 Does the company retain a sample of each lot or batch of a

13.0 QUALITY CONTROL DEPARTMENT

14.1.6.2 Does the facility have approved written procedures for

personnel and/or for goods. Clean areas shall be maintained

be handled and dispensed into containers under aseptic

dis-infected during operations, masks and gloves shall be

and flush the area effectively. Moreover particular attention

those that would be expected to be found in the filling

annually, and whenever significant modifications have

the chamber when a vacuum phase is part of the cycle.

product, and when a sample fails a test, the cause of failure

20.2 Is there adequate space for the orderly storage of material?

the frequencies of inspection and replacement?

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