 WHO/PQT: medicines Template

30 July 2020

Screening Checklist for Generic Products

1. PART A – ADMINISTRATIVE INFORMATION

Screening Checklist for Generic Products

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 WHO/PQT: medicines Template
30 July 2020

Dossier screening # Applicant short name Submission date

Screening date Recommendation

International Nonproprietary Name, strength, dosage form

Packaging, pack sizes and shelf life for each different packaging format

Comparator product and manufacturer

Product as per comparator list?
Biowaiver applied (yes, no), if YES, specify whether Biopharmaceutics Classification System
(BCS), additional strengths or other

Format of submission – confirm Common Technical Document format

Submission of API data – active pharmaceutical ingredient (API) master file, API
prequalification PQ-API), Certification of Suitability (i.e. CEP from European Directorate for the
Quality of Medicines) or full data, specify for each API

Full name of applicant and official address

Name, title and contact details of the designated contact person

List briefly all finished pharmaceutical product manufacturing sites

List briefly all API sources (manufacturing sites)

List briefly all contract research organizations involved

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2. Part B
Information required YES NO
(please comment below, if requirements not fully met)
1 Is the product strength currently invited?
Comment
Does the cover letter include a statement indicating that the
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information and data submitted is "true, complete and correct"?
Comment
3 Is a sample provided?
Comment
Has the applicant submitted a valid manufacturing license or valid
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Good Manufacturing Practice certificate for the FPP?
Comment
Has the applicant submitted valid marketing authorization data?
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(not mandatory)
Comment
If PQ-API, APIMF or CEP is used to present API data, are the
respective Confirmation of API Prequalification, Letters of Access
or EDQM CEP provided?
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For CEP, ensure the valid version on the EDQM website at the
time of screening is submitted or request the valid version.
Comment
If the full dossier route is used to present API data for an API site
that is not part of the same pharmaceutical group as the FPP
manufacturer, has a declaration been provided from the API
manufacturer that:
7 a) it has provided to the FPP manufacturer all confidential and
non-confidential information regarding the preparation, control
and stability of the API as per ICH1 module 3.S.2; and,
b) it will inform the FPP manufacturer of any changes to the
preparation, control and stability of the API?
Comment
If the full dossier route is used to present API data for an API site,
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has a complete module 3.2.S been provided?
Comment
Has the applicant submitted Quality Overall Summary – Product
9(a) Dossier (QOS-PD) and Quality Information Summary (QIS) as
Word documents using the most recent version?
Comment
Has the QOS and/or QIS template been altered (missing sections,
9(b)
subsections, tables, etc)?
Comment
Is the QOS-PD completed in an acceptable way, including
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references to dossier volumes and pages?
Comment
If a bioequivalence study is required (no biowaiver application),
11(a) has the applicant submitted the Bioequivalence Trial Information
(BTIF) as a Word document?
Comment

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ICH: International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. See:
www.ich.org/
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In addition to the BTIF, has the applicant provided MS Excel file

11(b) containing the AUC and Cmax data from the study (Appendix 1 to BTIF)
in Module 1.4.1?
Comment
If a biowaiver is requested, has the applicant submitted the appropriate
11(c) biowaiver application form (additional strengths, BCS, or zinc sulphate)
as a Word document?
Comment
Has the applicant submitted documentation regarding the
11(d) purchase, shipping, and storage of the comparator product used
in the bioequivalence study or biowaiver application?
Comment
Has the applicant provided a list of all bioequivalence studies,
including pilot studies, conducted with the proposed product i.e.,
11(e) same formulation and manufacturing process as that submitted for
prequalification, regardless of the comparator (reference) product
employed and regardless of the study outcome?
Comment
Has the applicant provided a list of all bioequivalence or
comparative bioavailability studies, including pilot studies,
conducted during pharmaceutical development (development of
11(f)
formulation and/or manufacturing processes) of the product,
regardless of the comparator (reference) product employed and
regardless of the study outcome?.
Comment
Has the bioequivalence study submitted in the dossier been
11(g) submitted to WHO Prequalification of Medicines before? (e.g. in
cases of co-packs and technology transfer)
Comment
For zinc sulfate formulations only — has an acceptability study
11(h) report or protocol for the study been submitted and screened by
prequalification clinical assessors?
Comment
Is data presented to support manufacturing at all the FPP
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manufacturing sites and preferably using all API sources?
Comment
Is the unit composition table presented fully and filled out
correctly, e.g. completed with appropriate titles e.g. Core tablet
(Layer 1, Layer 2, etc. as applicable), Contents of capsule,
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Powder for injection, and are excipient standards indicated (e.g.
United States Pharmacopeia (USP), British Pharmacopoiea, in
house)?
Comment
At the time of submission, is the stability data provided for at least
6 months at the accelerated condition and 6 months at the long-
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term condition and for at least two pilot scale batches of the FPP *
(three pilot scale batches of the API)?
Comment
If contract manufacturing is involved, are the responsibilities of all
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parties clearly defined
Comment
If technology transfer is involved, has validation data been
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presented
Comment
17 Is there data or a protocol presented for prospective validation of 3
consecutive production scale batches (of the largest proposed

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production size)
Comment
Does the manufacturer include in Section 2.3.R copies of
18 executed biobatch and proposed blank master production
record(s) for proposed production batch(es)
Comment
19 Is there data presented on validation of analytical procedures
Comment
Is there data on FPP batch sizes and composition of pilot and
20 production scale as well as those used in bioequivalence and
dissolution studies (e.g. 2.3.P.2.2.1)
Comment
Does the applicant indicate the full physical address of the FPP
manufacturing site including Unit and Block numbers, where
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applicable

Comment
22 Additional requirements for Sterile FPP are met? (see Part C)
Comment

* or for uncomplicated FPPs (see quality guideline), at minimum one pilot batch and one can be smaller as per
the quality guideline (Guidelines on submission of documentation for a multisource (generic) finished
pharmaceutical product for WHO prequalification: quality part).

Comments on deficiencies
with reference to table above and specific dossier sections

Additional data requested

(to be communicated to the applicant)

2. PART C – STERILE PRODUCT

If sterile API is purchased
i. Manufacturing process validation data including media fill results from a recent
media fill exercise/study for the aseptic process at the API manufacturing site is
submitted?

ii. Suitability of container closure — compatibility with API, demonstration of seal

integrity (e.g. by microbial ingress test, dye ingress test), suitability for
transportation to FPP site etc. Provided?
iii. Rubber stoppers/gasket: Supplier name, type and stopper number; evidence of
physicochemical testing as per USP <381> and its physiological safety as per
USP < 87>/<88>) or other equivalent requirements. Attestation from the
supplier that the closure is free of 2-mercapto benzothiazoles (2-MCBT) and
nitrosamines; compatibility with API (e.g. leachables/ extractables). Provided?
iv. Transportation studies — to demonstrate mode of transport chosen is
appropriate (e.g. through simulation). Provided?
v. A copy of blank and executed batch manufacturing record (BMR) including
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copies of all standard operating procedures (SOPs) pertinent to: sterilization of

manufacturing equipment, packaging materials and accessories; aseptic
procedures + media fill exercises; in-process controls. Provided?
vi. Filters: Make/type, article number and/or code, suppliers, filter validation data
(e.g. compatibility with the API, leachables/extractables, microbial retention for
sterilizing filters etc.). Provided?
vii. Description of manufacturing process/flow diagram: Environmental conditions
in the manufacturing, filling and packaging areas (temperature, pressure,
grades of area class etc.). Provided?
viii. Evidence of validation of the conditions/parameters used for the
sterilization/depyrogenation of the processing equipment and accessories,
filters and packaging components. Provided?
ix. Stability data generated using samples stored in inverted orientation where
rubber closures are used. Provided?

FPP
x. Procedures for receipt and handling of sterile API — SOPs on checks, tests,
handling, storage, sampling, dispensing etc., if applicable. Provided?
xi. Manufacturing process validation data including media fill results from a recent
media fill exercise/study for the aseptic processes at the FPP manufacturing
site. Provided?
xii. Suitability of container closure – compatibility with FPP, demonstration of seal
integrity (e.g. by microbial ingress test, dye ingress test), protection of product,
suitability for transportation of the FPP, suitability for use etc. Provided?
xiii. A copy of the blank and executed BMR and copies of all SOPs pertinent to:
sterilization of manufacturing equipment, packaging materials and accessories;
aseptic procedures + media fill exercises; in-process controls. Provided?
xiv. Filters: Make/type, article/model number and/or code, suppliers, filter validation
data (e.g. compatibility with the formulation ingredients,
leachables/extractables, microbial retention for sterilizing filters etc.). Provided?
xv. Description of manufacturing process/flow diagram: Environmental conditions
in the manufacturing, filling and packaging areas (temperature, pressure,
grades of area class etc.). Provided?
xvi. Evidence of validation of the conditions/parameters used for the
sterilization/depyrogenation of the processing equipment and accessories,
filters and packaging components. Provided?
xvii. Stoppers: Supplier name, type and stopper number of the rubber; evidence of
physicochemical testing as per USP <381> and its physiological safety as per
USP < 87>/<88>) or other equivalent requirements. Attestation from the
supplier that the closure is free of 2-mercapto benzothiazoles (2-MCBT) and
nitrosamines; compatibility with product (e.g. leachables/ extractables).
Provided?
xviii. Any holding periods for intermediates and supporting data submitted?
xix. Stability data generated using samples stored in inverted orientation where
rubber closures are used. Provided?
xx. Glass vials/ampoules: data to demonstrate that the glass meets the
requirements of USP <660> or other equivalent requirements. Provided?

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Diluents/ Solvents
xxi. QOS-PD (FPP part) completed for any diluent/solvent packaged with the
product?
xxii. Evidence of validation of the terminal sterilization process for the diluent/solvent
provided?
xxiii. Compatibility data for any diluents/solvents proposed to be used with the
product + stability data to support in-use period of reconstituted solutions.
Provided?
xxiv. If plastic containers are used, compatibility data with the diluent/solvent.
Provided?

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