Central Administration for Pharmaceutical Products

General Administration of Human Pharmaceuticals Registration

Administration of Technical Affairs for Human Pharmaceuticals
Procedure: Evaluation of (Composition & finished product specifications) /API specifications/S-Part
r Issuing Date: 14/04/2021

Guidance for submission of products for Evaluation of

(Composition & finished product specifications) /API specifications/S-Part
Scope:
This guidance applies for any human pharmaceutical product submitted for registration according to the
Ministerial decree 645/2018 or according to Emergency Use Authorization procedures.

Objective:
This guidance aims to provide applicants with the documents and information required for preparing and
submitting the files for evaluation of (Composition & finished product specifications) /API
specifications/S-Part (Submitted for evaluation prior to CTD file submission).
It should be noted that Egyptian Drug Authority has the right to request any further information or
documents, with a commitment that such requests are justifiable, and will be for the purpose of ensuring
quality, safety and efficacy of the submitted product.

Ite EUA products submitted

Prod according to Ministerial
m Required Documents ucts Decree 645/2018 for
No. evaluation of
FPP API s-
Comp. speck part
& s
specks

1 Application Form (Attached: Template #1) R R R R

On company letterhead signed, stamped and dated

2 Action Letter R R R R
3 Name approval R R R R
4 Fees Payment Receipt N.A R R R
5 Declaration states reference drug product used in the developmental N.R R N.R N.R
studies.
On Applicant Co. letterhead signed, dated and stamped
(Attached: Template #2)
6 Bioequivalence Unit approval for reference drug product which will be used N.R R N.R N.R
in bioequivalence or in-vitro study (If applicable).
7 Proposed API/ Semi-Finished or Intermediate product specifications R N.R R I

On Applicant Co. letterhead signed, dated and stamped

(Attached: Template #3)
8 CoA of API/ Semi-Finished or Intermediate product R F.I R I

On API manufacturer letterhead signed, dated and stamped

9 Detailed description of container closure system of API/ Semi-Finished or R N.R R I
Intermediate product
On API manufacturer letterhead signed, dated and stamped
10 Proposed composition certificate R R N.R N.R

On Applicant Co. letterhead signed, dated and stamped

(Attached: Template #4)
11 Declaration for calculation of equivalent base of API/ Semi-Finished or R R N.R N.R
Intermediate product (If applicable).
On Applicant Co. letterhead signed, dated and stamped
(Attached: Template #5)

Page 1 of 11
 Central Administration for Pharmaceutical Products
General Administration of Human Pharmaceuticals Registration
Administration of Technical Affairs for Human Pharmaceuticals
Procedure: Evaluation of (Composition & finished product specifications) /API specifications/S-Part
r Issuing Date: 14/04/2021
12 CoA of all excipient(s) R R N.R N.R

On excipient`s manufacturer letterhead signed, dated and stamped.

13 Proposed FPP specification R R N.R N.R

On Applicant Co. letterhead signed, dated and stamped

(Attached: Template #6)
14 Detailed description of container closure system of FPP R F.I N.R N.R

On Applicant Co. letterhead signed, dated and stamped

(Attached: Template #7)
15 Data certificate license for pharmaceutical plant (manufacturer of FPP) R R N.R N.R

Including the suitable production area and line for the FPP
16 Description of manufacturing process (flow diagram) F.I F.I N.R N.R

On FPP manufacturer letterhead signed, dated and stamped

(Attached: Template #8)
17 Drug Master File (Including the Restricted Part) N.R N.R N.R R

From the API Manufacturer (For Each API).

Attached with:
1-letter of access from the supplier.
2- Summary Sheet of stability file
(On the Applicant letterhead and according to the template on following
link:
https://docs.google.com/document/d/1jolSqWNMskUdTU9Tr-
6D1hO6zoF1CdEG/edit?usp=sharing&ouid=111862349084529780102&rtp
of=true&sd=true
▪ For details, please refer to this section in the quality module
submission guidance, on the following link:
https://drive.google.com/file/d/1M_ew9dDDgdyod61r7Md3wrppEftC7S4Y
/view?usp=sharing
18 Scientific committee approval (in case of non-reference products) R R R R

Notes:
▪ Semi-Finished or Intermediate product: Partially processed products that undergo further
manufacturing process before it becomes a bulk product.
▪ Fees Payment Receipt: 7,000 L.E. for each type of evaluation for products submitted according to
Ministerial Decree 645/2018.
N.B.:
-Different Strengths of the FPP and different API Suppliers are considered separate applications.
-The following data should be specified on the receipt: Trade Name, Dosage Form, Strength &Type
of evaluation required.

▪ For EUA Products Evaluation:

In case of registered products submitted for evaluation of new API manufacturer:
Document #2 should be replaced with: Registration License.
Document #3 should be replaced with: Variation Approval.

▪ Abbreviations
R : The Document is required.
N.R : The Document is Not Required.
F.I : The Document is required for information & will not be a subject for evaluation.
N.A : Not Applicable.
I : Included within the S-Part.
Page 2 of 11
 Central Administration for Pharmaceutical Products
General Administration of Human Pharmaceuticals Registration
Administration of Technical Affairs for Human Pharmaceuticals
Procedure: Evaluation of (Composition & finished product specifications) /API specifications/S-Part
r Issuing Date: 14/04/2021

Documents naming, file preparation and arrangement

1- All Templates :to be filled by the Applicant company on the Applicant’s letter head signed and stamped
by the applicant company , then attached as an Adobe Acrobat Document (.pdf)
-Link for editable copies of the templates:
https://docs.google.com/document/d/1kwzhfT2uCJLGVYATAlDeYvK9CkssUXJ4/edit?usp=sharing&ouid=111862349084529780102&rtpof=true&sd=true
2- All items from ( 1 to 17): documents should be submitted in form of separate Adobe Acrobat Document
(.pdf) under File names ;
Item No. in Adobe Acrobat Document (.pdf)
Check list File Name:
1 Application Form (Trade name-Concentration-Dosage form)

2 Action letter (Trade name-Concentration-Dosage form)

(In case of Under-Registration products)
Or Registration License (Trade name-Concentration-Dosage form)
(In case of Registered products)
3 Name approval -(Trade name-Concentration-Dosage form)
(In case of Under-Registration products)
Or Variation approval (Trade name-Concentration-Dosage form)
(In case of Registered products)
4 Fees Payment Receipt (Trade name-Concentration-Dosage form)

5 BE- (Trade name-Concentration-Dosage form)

6 Ref- (Trade name-Concentration-Dosage form)

7 API Specs- (Trade name-Concentration-Dosage form) (API name-API manuf.name)

8 CoA API- (Trade name-Concentration-Dosage form) (API name-API manuf.name)

9 CCS API- (Trade name-Concentration-Dosage form) (API name-API manuf.name)

10 Composition- (Trade name-Concentration-Dosage form)

11 Equivalence- (Trade name-Concentration-Dosage form)

12 CoA Inactive- (Trade name-Concentration-Dosage form)

13 FPP Specs- (Trade name-Concentration-Dosage form)

14 CCS FPP- (Trade name-Concentration-Dosage form)

15 Data Certificate- (FPP Manufacturer Plant Name)

16 Mfr process- (Trade name-Concentration-Dosage form)

17 DMF- (Trade name-Concentration-Dosage form)(API name-API manuf.name)

18 Scientific committee approval - (Trade name-Concentration-Dosage form)

3- All (.pdf) files should be uploaded in one Compressed folder named and dated:
(Trade name-generic –Concentration-Dosage form)(dd-mm-yy)

Page 3 of 11
 Central Administration for Pharmaceutical Products
General Administration of Human Pharmaceuticals Registration
Administration of Technical Affairs for Human Pharmaceuticals
Procedure: Evaluation of (Composition & finished product specifications) /API specifications/S-Part
r Issuing Date: 14/04/2021

Template #1
Application Form

Trade Name: This section to be filled by the Applicant company

Generic Name(s) + Strength(s): This section to be filled by the Applicant company
Dosage Form: This section to be filled by the Applicant company
Box Approval /Registration No: This section to be filled by the Applicant company
Applicant Company: This section to be filled by the Applicant company
Manufacturer of FPP: This section to be filled by the Applicant company
Packaging & Batch release site: This section to be filled by the Applicant company
Manufacturer(s) of API: This section to be filled by the Applicant company
Reference of Quality Standards of API: This section to be filled by the Applicant company
(USP, Ph. Eur. , B.P….)
Solvent’s Registration status & supplier This section to be filled by the Applicant company
(If applicable):
Type of Evaluation required: This section to be filled by the Applicant company
Notes: This section to be filled by the Applicant company

Contact Information:

Applicant Company regulatory FPP Manufacturer (R&D department)

Representative. Representative.

- Title: This section to be filled by the Applicant company This section to be filled by the Applicant company

- Name: This section to be filled by the Applicant company This section to be filled by the Applicant company

- Mobile: This section to be filled by the Applicant company This section to be filled by the Applicant company

- E-mail: This section to be filled by the Applicant company This section to be filled by the Applicant company

- - Registration Manager
-

- - - Name :
- Signature:
- Date:
-

Company Stamp

Notes on submission of Template #1: (To be deleted)

1- This template should be copied and submitted on Applicant Company letterhead.

Page 4 of 11
 Central Administration for Pharmaceutical Products
General Administration of Human Pharmaceuticals Registration
Administration of Technical Affairs for Human Pharmaceuticals
Procedure: Evaluation of (Composition & finished product specifications) /API specifications/S-Part
r Issuing Date: 14/04/2021

Template #2

Title: Declaration states reference drug product used in developmental studies

Applicant Company: This section to be filled by the Applicant company

Trade Name: This section to be filled by the Applicant company
Generic Name(s) + Strength(s): This section to be filled by the Applicant company
Dosage Form: This section to be filled by the Applicant company

Reference Product Details:

Reference Drug Product

Name, strength and dosage This section to be filled by the Applicant company
form of reference Product
Name of MAH,Manufacturer This section to be filled by the Applicant company
and Country of origin

Applicant Company Signature, Date & Stamp:

Notes on submission of Template # 2: (To be deleted)

1-This template should be copied and submitted on Applicant Company letterhead.

Page 5 of 11
 Central Administration for Pharmaceutical Products
General Administration of Human Pharmaceuticals Registration
Administration of Technical Affairs for Human Pharmaceuticals
Procedure: Evaluation of (Composition & finished product specifications) /API specifications/S-Part
r Issuing Date: 14/04/2021

Template #3
Title: Proposed API/ Semi-Finished or Intermediate product specifications

Applicant Company: This section to be filled by the Applicant company

Trade Name: This section to be filled by the Applicant company
Generic Name(s) + This section to be filled by the Applicant company
Strength(s):
Dosage Form: This section to be filled by the Applicant company

Test / Analytical Method Acceptance Criteria Reference

Applicant Company Signature, Date & Stamp:

Notes on submission of Template # 3: (To be deleted)

1- This template should be copied and submitted on Applicant Company letterhead.

2- Universal tests are mandatory (Description, Identification, Assay, Impurities).
3- The Analytical method should be specified under the name of the test in case of:
-Instrumental Methods used: (for example: Identification by (IR, UV, HPLC, TLC), Assay by
(HPLC), Residual Solvents by (GC), Polymorphism by (XRPD, DSC)).
-Specific Analytical Method used: (for example: Water Content by (Karl Fischer or Loss on Drying),
Particulate Matter by (Light Obscuration or Microscopic), and Uniformity of Dosage Unit by
(Content Uniformity or Weight Variation).
4- Reference: (for example: BP, USP, JP, Ph. Eur., ICH, In-house), with detailed data (current edition
of pharmacopeia, General chapter number, ICH guidelines number … etc)

Page 6 of 11
 Central Administration for Pharmaceutical Products
General Administration of Human Pharmaceuticals Registration
Administration of Technical Affairs for Human Pharmaceuticals
Procedure: Evaluation of (Composition & finished product specifications) /API specifications/S-Part
r Issuing Date: 14/04/2021

Template #4

Title: Proposed composition certificate.

Applicant Company: This section to be filled by the Applicant company

Trade Name: This section to be filled by the Applicant company
Generic Name(s) + This section to be filled by the Applicant company
Strength(s):
Dosage Form: This section to be filled by the Applicant company

Ingredient(s) Amount/ Unit Percentage Function Reference

% w/w or (Compendial
% w/v or In-house)
API

Excipient

Total weight / Volume

Applicant Company Signature, Date & Stamp:

Notes on submission of Template # 4: (To be deleted)

1- This template should be copied and submitted on Applicant Company letterhead.

2- API (s), it’s (their) hydrate(s) and salt form(s) with its (their) quantity (ies) per unit dose is (are)
specified.
3- Grades of excipient should be mentioned beside excipient name.
4- Coat or Capsule Shell should be mentioned separate from the core or capsule content.
5- Weight of core tablet or content of capsule should be mentioned separately from total weight.
6- Solvents and Nitrogen Gas used during manufacturing process: to be mentioned as manufacturing
auxiliary agent.
7- Composition of all components used as mixtures should be mentioned in details and submitted on
supplier’s Letterhead (e.g. Pellets, premixes, colorants, coatings, capsule shells and imprinting inks).
8- The Overage should be mentioned, and justification should be submitted on a separate document.
9- Reconstitution Solvents should be mentioned if present.(Not applicable for solvents with registration
license).
10- In case of Pellets & Premix: composition on supplier letterhead should be attached.

Page 7 of 11
 Central Administration for Pharmaceutical Products
General Administration of Human Pharmaceuticals Registration
Administration of Technical Affairs for Human Pharmaceuticals
Procedure: Evaluation of (Composition & finished product specifications) /API specifications/S-Part
r Issuing Date: 14/04/2021

Template #5

Title: Declaration for calculation of

-Equivalent base of API/ Semi-Finished or Intermediate product

-Quantity of pellets / Premix

Applicant Company: This section to be filled by the Applicant company
Trade Name: This section to be filled by the Applicant company
Generic Name(s) + This section to be filled by the Applicant company
Strength(s):
Dosage Form: This section to be filled by the Applicant company

Calculations:

Applicant Company Signature, Date & Stamp:

Notes on submission of Template # 5: (To be deleted)

1- This template should be copied and submitted on Applicant Company letterhead.

2- Detailed calculation steps should be provided.

Page 8 of 11
 Central Administration for Pharmaceutical Products
General Administration of Human Pharmaceuticals Registration
Administration of Technical Affairs for Human Pharmaceuticals
Procedure: Evaluation of (Composition & finished product specifications) /API specifications/S-Part
r Issuing Date: 14/04/2021

Template # 6
Title: Proposed FPP specifications.
Applicant Company: This section to be filled by the Applicant company
Trade Name: This section to be filled by the Applicant company
Generic Name(s) + This section to be filled by the Applicant company
Strength(s):
Dosage Form: This section to be filled by the Applicant company

Test / Analytical Method Acceptance Criteria Reference

Applicant Company Signature, Date & Stamp:

Notes on submission of Template # 6: (To be deleted)

1- This template should be copied and submitted on Applicant Company letterhead.

2- Universal tests are mandatory (Description, Identification, Assay, Impurities).
3- The Analytical method should be specified under the name of the test in case of:
-Instrumental Methods used: (for example: Identification by (IR, UV, HPLC, TLC), Assay by
(HPLC), Residual Solvents by (GC), Polymorphism by (XRPD, DSC)).
-Specific Analytical Method used: (for example: Water Content by (Karl Fischer or Loss on Drying),
Particulate Matter by (Light Obscuration or Microscopic), and Uniformity of Dosage Unit by
(Content Uniformity or Weight Variation).
4- Reference: (for example: BP, USP, JP, Ph. Eur., ICH, In-house), with detailed data (current edition
of pharmacopeia, General chapter number, ICH guidelines number … etc)

Page 9 of 11
 Central Administration for Pharmaceutical Products
General Administration of Human Pharmaceuticals Registration
Administration of Technical Affairs for Human Pharmaceuticals
Procedure: Evaluation of (Composition & finished product specifications) /API specifications/S-Part
r Issuing Date: 14/04/2021

Template # 7

Title: Description of container closure system for FPP.

Applicant Company: This section to be filled by the Applicant company

Trade Name: This section to be filled by the Applicant company
Generic Name(s) + This section to be filled by the Applicant company
Strength(s):
Dosage Form: This section to be filled by the Applicant company

FPP Container Closure System:

Applicant Company Signature, Date & Stamp:

Notes on submission of Template # 7: (To be deleted)

1- This template should be copied and submitted on Applicant Company letterhead.

2- Detailed description of container closure system: (1ry, 2ry packaging components, unit count, fill
size, container volume, dispensing or administration device … etc.)

Page 10 of 11
 Central Administration for Pharmaceutical Products
General Administration of Human Pharmaceuticals Registration
Administration of Technical Affairs for Human Pharmaceuticals
Procedure: Evaluation of (Composition & finished product specifications) /API specifications/S-Part
r Issuing Date: 14/04/2021

Template # 8

Title: Description of manufacturing process of FPP (flow diagram).

Applicant Company: This section to be filled by the Applicant company

Trade Name: This section to be filled by the Applicant company
Generic Name(s) + This section to be filled by the Applicant company
Strength(s):
Dosage Form: This section to be filled by the Applicant company

Flow Diagram:

FPP manufacturer Signature(s), Date & Stamp:

Applicant Company Stamp:

Notes on submission of Template # 8: (To be deleted)

1- This template should be copied and submitted on FPP manufacturer letterhead.

2- Flow diagram illustrating manufacturing process including (input materials, order of addition,
manufacturing steps, equipment used with parameters, in-process control… etc.).

Page 11 of 11