MANUFACTURER REGISTRATION

REQUIREMENT DOCUMENT FOR

MANUFACTURER REGISTRATION

2
 ANNEX I

APPLICATION FORM FOR REGISTRATION OF MANUFACTURER

H.E. Minister ,

We have honor to apply for registration of the Manufacturer named :

...............................................................................................................

In support of this application, the following information is provided :

A- Administrative dossier :

1- Information on the applicant ..................................................................... €

2- Information on the Manufacturer ................... ........................................... €

3- G.M.P. Certificate ...................................................................................... €

4- Other certificate ......................................................................................... €

5- Does the Manufacturer have Registered in other country ......................... €

6- License to operate in the Country of Origin ............................................. €

7- Representative Office in Cambodia or Local representative ( If available ) €

8- Business Information ................................................................................... €

9- Has the Manufacturer been inspected by your government ......................... €

10- Has the Manufacturer been inspected by other government......................... €

11- Organization Chart and list of qualified employees .................................... €

12- Annual sales turnover in the previous three years...................................... €

B- Technical dossier :

a- Manufacturing information ......................................................................... €

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 1- Master plan of factory ......................................................................... €

2- Organization chart and list of the qualify employees ........................... €

3- List of the manufactured products........................................................ €

4-List of Repackaged products................................................................. €

5- List of Sterile products.......................................................................... €

6-List of Beta-Lactam ......... ........................................................... ........ €

7- List of Equipment used at each production site ................................... €

8- Maintenance and Inspection................................................................. €

b- Quality information ....................................................................................... €

1-Organization chart and list of the qualify employees ........................... €

2- Do you have your own quality control................................................... €

3- Do you have a Research and Development Laboratory ...................... €

4- Does the quality control laboratory hold any quality certificate or

accreditation?........................................................................................ €

5- Maintenance.......................................................................................... €

6- Stability................................................................................................... €

7- Storage................................................................................................... €

c- Quality Assurance

1-Organization chart and list of the qualify employees ............................ €

2- List of products subject to customer complaints................................... €

3- List of Recalled products ..................................................................... €

We thank you in advance, for accepting our application form .

Sincerely Yours

Capital ( ) , ...........2023

4
 ( Signature , Name , Seal )

ANNEX II

LIST OF DOCUMENTS REQUIRED

FOR
PHARMACEUTICAL MANUFACTURER REGISTRATION

The applicant should provide all information regarding the Manufacturer

A- ADMINISTRATIVE DOSSIER

1- Information on the Applicant:

Name :....................................................................................
Address : ...................................................................................
Phone : ..................................................................................
Fax : ..................................................................................
E-mail : ..................................................................................

2- Information on the Manufacturer

Name : Wenovo Pharmaceuticals

Address : Plot No. 31,32 Punjab small Industrial Estate Taxila Pakistan
Phone : 051-5497088
Fax : 05-5497088
E-mail : wenovopharmaceutical@gmail.com

3- Does the Pharmaceutical Manufacturer have a GMP certificate

- Yes € (Attach recent Color copy of GMP

Certificate Certified by the Embassy of Cambodia in
the country where the Certificate issued )

- No € ( Give reason why ? )

.......................................................................................................................
.......................................................................................................................

4- Does the Pharmaceutical Manufacturer have other Certificates ?

- Yes € Attach recent certified true copy of Certificate

( Certify by Notary / Lawyer )

5
 - No €

5- Does the Pharmaceutical Manufacturer have registered in other

Country ?
- Yes € Attach list of countries where the Manufacturer has

registered with recent certified true copy of certificate

( Certify by Notary / Lawyer )

- No €
6- License to Operate as a Pharmaceutical Manufacturer

- Yes € Attach recent certified true copy of Certificate

( Certify by Notary / Lawyer )

- No € ( Give reason why ? )

.......................................................................................................................
.......................................................................................................................

7- Does the Pharmaceutical Manufacturer have Representative office in

Cambodia ?

- Yes €
- Name : ............................................................................................
- Address : ............................................................................................
- Telephone : ............................................................................................
- Fax : ...........................................................................................
- E mail : ...........................................................................................
- No €

8- Business information

a- Individual €

b- Partnership €

c- Corporation €

d- Others ( Specify ) €

9- Has the Manufacturer been inspected by your government

- Yes € ( Copy the report of last inspection )

.......................................................................................................................
- No € ( Give reason and explain how you ensure your GMP
Certificate continues to comply )
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 .....................................................................................................................
......................................................................................................................
10- Has the Manufacturer been inspected by other governments,
organizations or others ?

- Yes € (Copy the report of last inspection)

.......................................................................................................................

- No €

11- Organization Chart and list of qualified employees

(Function & Qualification: See Annex II A1)

12- Annual sales turnover in the previous three years

(Domestic & Export)

Annual sales turnover in the previous three years

a-Domestic in US Dollars b-Export in US Dollars

2019-2020: 2019-2020:
2020-2021: 2020-2021:
2021-2022: 2021-2022:

-Export to Which Country:

13- Total Number of Staff :

-Technical staff:

- workers :

B- TECHNICAL INFORMATION

a-Manufacturing information

1-Year of Establishment :

2- Master plan in Square meters

- Master plan of the factory

- Retailed plan of every building

. Building No 1
7
 . Building No 2

. Building No 3

. ...........................................

. ...........................................

-Total floor area of the factory

............................................................................................................

. Total floor area of the production facility

.................................................................................................

. Total floor area of the control Laboratory.

.................................................................................................

. Total floor area of the warehouse

...............................................................................................

. Total floor area of the administrative office

................................................................................................

. Others
..............................................................................................
... .............................................................................................
...
…..............................................................................................

3-Organization chart and list of qualified employees in the Production

Department ( Function & Qualification ) ( See Annex II A 2)

4-List of the manufactured products ( See Annex II B )

5-List of the repackaged products ( See Annex II C )

6-Sterile product

Provide the list of products and methods of sterilization ( See Annex II D )

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7-Beta – Lactam

-Are these productions facilities in a separate building ?

. Yes € (Please provide list of product)

. No € If no, Please explain how production is isolated

.......................................................................................................................
.......................................................................................................................

8-List of equipment used at each production site ( See Annex II E )

9- Maintenance & inspection

a- Do you regularly maintain the equipment

. Yes € If yes, how often a year

.......................................................................................................................
No € If no, please provide the reason
.......................................................................................................................
.......................................................................................................................
b- Do you regularly inspect the production equipment

. Yes € If yes, how often a year

.......................................................................................................................

. No € If no, please provide the reason

.......................................................................................................................
………………………………………………………………………………………

b- Quality control Information

1-Provide Organization chart & List of qualified employees of the quality

control department ( Function & Qualification See Annex II F )

2-Do you have your own Quality Control Laboratory?

. Yes €
. No €

If no, how and where are tests performed ? Please provide the
name and address of the quality control laboratory
.................................................................................................
.................................................................................................
Name :
.................................................................................................

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 Address : ................................................................................
.................
.................................................................................................
3 -Do you have a Research and Development Laboratory ?

. Yes € If yes, please describe the research activities ( See

Annex II B – b : Raw materials )
..................................................................................................................
. No €

4-Does the quality control laboratory hold any quality certificate or

accreditation ?

. Yes € If yes, please attach the certified true copy of

certificate ( Certified by Notary / Lawyer ) .
. No €

5- Maintenance

- Do you regularly maintain the equipment?

. Yes € If yes, how often a year

.................................................................................................

………………………………………………………………………
. No € If no, please provide the reason and describe
how you guarantee he accuracy of your
equipment .
................................................................................................
...............................................................................................
6- Stability

- Are stability tests performed?

. Yes €
. No € If no, state the reason and describe how you
determine the shelf life of the product ?
............................................................................................................
............................................................................................................
7- Storage

Describe your storage facilities

..............................................................

C- Quality Assurance

a- Please provide an Organization chart & List of qualified employees in

the Quality Assurance (See Annex II G )

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 b- Explain the procedure for releasing batches of finished product :
.....................................................................................................................
....................................................................................................................
.....................................................................................................................
c-Are results of control samples of each batch retain ?

. Yes €
. No € If no, please state the reason why ?
..................................................................................................................
..................................................................................................................

d-Do you keep samples of every batch ?

. Yes € If Yes, indicate how long you keep the samples

.................................................................................................
. No € If no, state the reason why ?
................................................................................................
.................................................................................................

e-Are these kept in the original containers ( Marketed Packaging ) ?

. Yes €

. No € If no, state the reason why ?

................................................................................................
................................................................................................
................................................................................................

f- Customer Complaints & Product recalls

a- Please provide a list of products that have been subject to customer

complaints ( See Annex II H )

b-Do you have a written procedure to address complaint ?

. Yes € If yes, describe your procedures for handling

customer complaints
............................................................................................................
............................................................................................................

. No € If no, describe how customer complaints are

dealt with
............................................................................................................
............................................................................................................

c-Please provide a list of product recalled ( See Annex II I )

d-Do you have a written recall procedure ?

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 .Yes € If yes, describe your procedures for product recalls
..........................................................................................................
............................................................................................................
. No € If no, provide the reason
............................................................................................................
............................................................................................................

DECLARATION

I, the undersigned hereby declare that all the information given above is true, and

I take full responsibility for all consequences that might arise from false or erroneous

information . If required , I will co- operate with any official of the Ministry of health in

Cambodia in performing personal inspection of manufacturing facilities and records.

Name of applicant :

Signature :

Date :

Company Stamp :

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 ANNEX II A1

1-ORGANIZATION CHART OF MANUFACTURER

2-LIST OF QUALIFIED EMPLOYEES

No Name Qualification Responsibility Age Experience

s
A- administrative
section
1- Mr. Arshad Mahmood Ph.D. Chemistry Managing Director 45 20 years
2- Brgd. Dr. Mahboob M.B.B.S. Director 65 40 years
Sardar
3- Mr. Rizwan Ahmed Graduation Administrative 37 10 years
Manager
B- Production
section
1- Mr. Saqib Yaqub Awan Pharm. D. Production 45 20 years
Manager
2- Mr. Abdul Rehman Pharm. D. Asst. Production 28 6 years
Manager
3- Ms. Javeria Yusaf Pharm. D. Production 26 4 years
Pharmacist
C- Quality section
1- Mr. Ziad Hussain M.Sc. Chemistry Quality Control 48 23 years
Manager
2- Mr. Tufail Ahmad M.Sc. Chemistry Sr. Quality Control 28 7 years
Officer
3- Ms. Saman Arif B.Sc. Chemistry Sr. Quality Control 23 3 years
Officer
4- Ms. Hamyail Riaz B.Sc. Chemistry Sr. Quality Control 25 4 years
Officer
5- Ms. Fari Malik B.Sc. Chemistry Jr. Quality Control 21 1 years
Officer
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6- Ms. Kinza Graduate Jr. Quality Control 20 1 years
Officer
7- Ms. Iqra Azmat Graduate Lab Attendant 22 2 years
8- Mr. Hammad Ali M. Phil Sr. Microbiologist 30 5 years
Microbiology
9- Mr. Inayat - Lab Attendant 22 6 years
D- Others
1- Ms. Shanza Habib Pharm. D Quality Assurance 32 8 years
Manager
2- Ms. Amber Riaz Intermediate QA Officier 18 2 years

Name of Authorized person :

Signature :

Date :

Stamp :

14
 ANNEX II A2

1-ORGANIZATION CHART OF THE PRODUCTION DEPARTMENT

2- LIST OF QUALIFIED EMPLOYEES IN THE PRODUCTION DEPARTMENT

No Name Qualification Responsibility Age Experience

s
A- Manufacturing
section
1- Mr. Saqib Yaqub Awan Pharm. D. Production 45 20 years
Manager
2- Mr. Abdul Rehman Pharm. D. Asst. Production 28 6 years
Manager
3- Ms. Javeria Yusaf Pharm. D. Production 26 4 years
Pharmacist

Name of Authorized person :

15
 Signature :

Date :

Stamp :

ANNEX II B

LIST OF MANUFACTURED PRODUCTS

a- Finished dosage form

Table 1 : TABLETS

No Product’s name INN name Packing Date of No of Total

size M. A . M.A. No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

Name of Authorized person :

Signature :

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 Date :

Stamp :

Table 2 : COATED TABLETS

No Product’s name INN name Packing Date of No of Total

size M. A . M.A. No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

Name of Authorized person :

Signature :

Date :

Stamp :

17
 Table 3 :CAPSULES

No Product’s name INN name Packing Date of No of Total

size M. A . M.A. No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

18
 Name of Authorized person :

Signature :

Date :

Stamp :
Table 4 :SYRUPS

No Product’s name INN name Packing Date of No of Total

size M. A . M.A. No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

19
 Name of Authorized person :

Signature :

Date :

Stamp :
Table 5 : Granular Sachets

No Product’s name INN name Packing Date of No of Total

size M. A . M.A. No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

20
 Name of Authorized person :

Signature :

Date :

Stamp :
Table 6 : Powder for Syrup

No Product’s name INN name Packing Date of No of Total

size M. A . M.A. No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

21
 Name of Authorized person :

Signature :

Date :

Stamp :
Table 7 : Oral drops

No Product’s name INN name Packing Date of No of Total

size M. A . M.A. No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

Name of Authorized person :

22
 Signature :

Date :

Stamp :

Table 8 : Creams

No Product’s name INN name Packing Date of No of Total

size M. A . M.A. No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

23
 Name of Authorized person :

Signature :

Date :

Stamp :
Table 9 : Parenteral Pharmaceutical forms ( Injectable forms )

No Product’s name INN name Packing Date of No of Total

size M. A . M.A. No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

24
 Name of Authorized person :

Signature :

Date :

Stamp :

Table 10 : Other Pharmaceutical forms

No Product’s name INN name Packing Date of No of Total

size M. A . M.A. No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

Name of Authorized person :

25
 Signature :

Date :

Stamp :

Table 11 : Other Products ( Veterinary products , Cosmetic products ,

Traditional medicine products , Health supplement products ,
Medical Devices & Reagents )

No Product’s name INN name Packing Date of No of Total

size M. A . M.A. No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

Name of Authorized person :

26
 Signature :

Date :

Stamp :

b-Raw materials

No Product’s name Packing size Date of No of Total No

M. A . M.A. per year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

Name of Authorized person :

Signature :

Date :

Stamp :

27
 c- Bulk Drugs

No Product’s name INN name Packing Date of No of Total

size M. A . M.A. No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

Name of Authorized person :

28
 Signature :

Date :

Stamp :

29
 ANNEX II C

LIST OF REPACKAGED PRODUCTS

Table 1 : TABLETS

No Product’s INN Packing Date No Name of Country’s Total

name name size of of Manufacturer Name of No
M. M. of Bulk drug Manufacturer per
A. A. of Bulk drug year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

Name of Authorized person :

Signature :

Date :

Stamp

30
 Table 2 : COATED TABLETS

No Product’s INN Packing Date No Name of Country’s Total

name name size of of Manufacturer Name of No
M. M. of Bulk drug Manufacturer per
A. A. of Bulk drug year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

Name of Authorized person :

Signature :

Date :

Stamp :

31
 Table 3 : CAPSULES

No Product’s INN Packing Date No Name of Country’s Total

name name size of of Manufacturer Name of No
M. M. of Bulk drug Manufacturer per
A. A. of Bulk drug year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

Name of Authorized person :

Signature :

Date :

Stamp

32
 Table 4 : OTHER PHARMACEUTICAL FORMS

No Product’s INN Packing Date No Name of Country’s Total

name name size of of Manufacturer Name of No
M. M. of Bulk drug Manufacturer per
A. A. of Bulk drug year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

Name of Authorized person :

Signature :

Date :

Stamp

33
 ANNEX II D

LIST OF STERILE PRODUCTS

No Product’s INN Packing Date of No of Sterilization Total

name name size M. A . M.A. Method No per
year

Note : - Date of M. A. : Date of Marketing Authorization .

- No. of M. A. : Number of Marketing Authorization

Name of Authorized person :

Signature :

Date :

Stamp

34
 ANNEX II E

LIST OF EQUIPMENT USED IN PRODUCTION

Table 1 : TABLET SECTION

No Process Equipment Date in Capacity Origin

service
1- Homogenisation 1Tumbler mixer 1982 1.200 kg China
1 Soneco mixer 1987 2.000 kg Germany
1 Trayvou balance
etc................
2- Compression

Name of Authorized person :

Signature :

Date :

Stamp :

35
 Table 2 : CAPSULE SECTION

No Process Equipment Date in Capacity Origin

service

Name of Authorized person :

Signature :

Date :

Stamp :

36
 Table 3 : OTHERS SECTIONS

No Process Equipment Date in Capacity Origin

service

Name of Authorized person :

Signature :

Date :

Stamp
37
 ANNEX II F

1-ORGANIZATION CHART OF QUALITY CONTROL DEPARTMENT

2- LIST OF QUALIFIED EMPLOYEES IN QUALITY CONTROL DEPARTMENT

No Name Qualification Responsibility Age Experience

s
1- Mr. Ziad Hussain M.Sc. Chemistry Quality Control 48 23 years
Manager
2- Mr. Tufail Ahmad M.Sc. Chemistry Sr. Quality Control 28 7 years
Officer
3- Ms. Saman Arif B.Sc. Chemistry Sr. Quality Control 23 3 years
Officer
4- Ms. Hamyail Riaz B.Sc. Chemistry Sr. Quality Control 25 4 years
Officer
5- Ms. Fari Malik B.Sc. Chemistry Jr. Quality Control 21 1 years
Officer
6- Ms. Kinza Graduate Jr. Quality Control 20 1 years
Officer
7- Ms. Iqra Azmat Graduate Lab Attendant 22 2 years
8- Mr. Hammad Ali M. Phil Sr. Microbiologist 30 5 years
Microbiology
9- Mr. Inayat - Lab Attendant 22 6 years

Name of Authorized person :

Signature :

Date :

Stamp :

38
 ANNEX II G

1-ORGANIZATION CHART OF QUALITY ASSURANCE SECTION

2- LIST OF QUALIFIED EMPLOYEES IN QUALITY ASSURANCE SECTION

No Name Qualification Responsibility Age Experience

s
1- Ms. Shanza Habib Pharm. D Quality Assurance 32 8 years
Manager
2- Ms. Amber Riaz Intermediate QA Officier 18 2 years

Name of Authorized person :

Signature :

Date :
39
 Stamp :

ANNEX II H

LIST OF PRODUCT COMPLAINTS

No Product’s Name INN name Number of Type of complaint

complaints serious/ ........

Name of Authorized person :

Signature :

Date :

Stamp :

40
 ANNEX II I

LIST OF RECALLED PRODUCTS

No Product’s Name INN name Pack size Number of Reason of

and batch No products recall
recalled

Name of Authorized person :

Signature :

Date :

Stamp :

41
 RECEPTION ACKNOWLEDGEMENT

No.
1- Applicant ( Contact person / Local distributor ):

- Name : .......................................................................................................

- Address : …....................................................................................................

- Telephone : ........................................................................................................

- Fax : .......................................................................................................

- E- mail : .......................................................................................................

2- Company Name ( Manufacturer / company ):

- Name : .......................................................................................................

- Address : .......................................................................................................

- Telephone : .......................................................................................................

- Fax : .......................................................................................................

- E- mail : .......................................................................................................

3- Reception Acknowledgement :

-Name of officer receiving the application form :

...................................................................................................................

- Date of receipt of application form :

.......................................................................................................................

- Identifying Number
: .....................................................................................................................
.

- Signature
: .....................................................................................................................
.
42
- Receptionist’s Comment :

........................................................................................................................

Thanks

43
Note:

. All certificates/documents shall be in the English

language.Where certificates/documents are not in the
English language are accurate translation shall be
provided.

. The Manufacturer should provide new GMP evidence

before the expiry date of the submitted documentary
evidence of GMP conformance.

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