Standard Operating Procedure

Title Control of Documents

Department Quality Assurance

SOP NO Issue NO Revision No Issue date Effective Date Review Date

SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST

Reviewed by AHMED ESSAM PRODUCTION MANAGER

Approved by MOHAMED MOSA Q.A. MANAGER

Document Pages: 14 pages

.Copy No: ( 01 )
SOP/QA001
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

1. PURPOSE:
1.1. To lay down a procedure for control of documents and documented data.
2. SCOPE:
2.1. This SOP is applicable for the control/management of documents and documented data at
NUNU Company for baby care products
3. RESPONSIBILITY:
3.1. User Department Personnel:
3.1.1. Prepare document as applicable
3.1.2. Request issuance of new SOP, logbook, formats and record
3.1.3. Retrieve the old SOPs, Logbook, formats and records to QA after execution of new document.
3.2. Q.A Personnel:
3.2.1. Prepare the master and controlled copy of document
3.2.2. Issue, distribute, archive, and destroy the master and controlled copy of documents
3.2.3. Maintain and control the documentation system
3.3. All Department Manager:
3.3.1. shall be responsible to follow this SOP for maintaining control on all documents and
documented data or records.
3.4. Quality Assurance Manager:
3.4.1. Ensue implementation of instruction laid down to the procedure
3.4.2. Approve the documents after being prepared by user department and reviewed by relevant
manager or designee or by quality assurance personnel.
4. DEFINITIONS:
N.A.
5. ABBREVIATIONS:
QA: Quality Assurance.
SOP: Standard Operation Procedure.
6. FORMS USED:
6.1. Document Requisition, Modify, obsolete, Request Form No# F0/SOP/QA001
6.2. Document Requisition, Modify, obsolete, Request logbook Form No# F02/SOP/QA001
6.3. Distribution and withdrawal form # F03/SOP/QA001

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 1 of 15
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

6.4. Documents Master list form # F04/SOP/QA001.

6.5. SOPs index Form # F05/SOP/QA001.
6.6. QA Stamps (Annex 1)
7. PROCEDURE:
7.1. Documents and Data Control:
7.1.1. Documents and Data Control is a function or department which keeps track of all
documentation, specifications, and processes.
7.1.2. The purpose is to ensure that everyone uses the correct and current document processes
and specifications.
7.2. Control of Documents:
7.2.1. After preparation, the original signed documents shall be submitted on A4 size paper
to the QA department to control & storage.
7.2.2. the originally signed copies of all documents shall be stamped as ‘ORIGINAL’ stamp
using green ink, on the back or behind of each & every page at the centre of the page.
It is referred to as original or master copy.
7.2.3. For the preparation of controlled copies of the master copy, authorized QA personnel
shall arrange photocopies of the master copy on plain A4 size paper, using one side of
the plain paper.
7.2.4. Each page of the photocopy of the master copy shall be stamped as ‘DOCUMENT
CONTROLLED’ using blue ink, on the top right corner.
7.2.5. A controlled copies shall be distributed to related departments using a distribution and
withdrawal form # F01/SOP/QA001, A record of controlled copies shall be
maintained.
7.2.6. All distributed Copies shall be recorded in Documents Master list form No #
F04/SOP/QA001.
7.2.7. All withdrawal copies old version must be destructed.
7.2.8. While issuing for information copy of the documents and data, the photocopy of the
master copy shall be stamped as "FOR INFORMATION’ using blue ink, on the top
right corner of each page
7.2.9. ‘FOR INFORMATION’ copy shall not be required to be retrieved.
7.2.10. The “ORIGINAL COPY” stamp, “DOCUMENT CONTROLLED” stamp,
“OBSELETE COPY” stamp, “FOR INFORMATION” stamp, and all other related
stamps shall be under the control of the QA documentation personnel/ Authorized QA
person.

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 2 of 15
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

7.2.11. Only QA shall retain a computer soft copy of SOPs with the format used of SOPs of all
departments and other master documents.
7.2.12. QA department shall store the computer soft copies (SOP) in department-wise folders.
7.2.13. In these folders create folder name “MASTER SOPs”. The “MASTER SOPs” folder
shall store respective SOPs and their forms along with SOPs index Form #
F05/SOP/QA001.
7.2.14. The computer system in which all documents preserved in soft copy shall be password
protected and password shall be available to Q.A specialist and section head only.
7.3. Obsolete Documents and Data:
7.3.1. Obsolete documents are those which are no longer required, replaced.
7.3.2. These documents may be identified as part of the review process and shall be removed
from the master documents and appropriately archived to prevent unintended use.
7.3.3. Archived documents must be retained and accessible for system evaluation and legal
purposes.
7.3.4. The “OBSOLETE COPY” of the old version of a master copy shall be stamped with
red ink on front of each & every page at the centre of each page.
7.4. Requisition/Issuance/Retrieval of Logbooks (Documents and Data Control):
7.4.1. The user department shall send the approved requisition, before the implementation of
logbook/formats/protocols to the QA department as per Document Requisition,
Modify, obsolete, Request Form No# F01/SOP/QA001 at least one week before.
7.4.2. The authorized QA personnel shall issue the logbook as per approved requisition.
issuance & retrieval process shall be recorded on Document Requisition, Modify,
obsolete, Request Form No# F01/SOP/QA001.
7.4.3. All filled logbooks shall be retrieved at end of the year except those logbooks which
are used to maintain the stock.
7.4.4. Logbooks that are used to maintain the stock same shall be continued till a change in
the format or completion.
7.4.5. If there is requirement for a second logbook in the same calendar year, same logbook
shall be issued after retrieval of the previous logbook. the issuance and retrieval
process shall be recorded in Document Requisition, Modify, obsolete, Request Form
No QA.SOP002F01.01.
7.5. Requisition/Issuance/Retrieval of Formats (Documents and Data Control):
7.5.1. The user department shall send the approved requisition as per Document Requisition,
Modify, obsolete, Request Form No QA.# F01/SOP/QA001, one week before to the
QA Department.
Name Title Sign/ Date
Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 3 of 15
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

7.5.2. For issuance of format, the authorized QA person shall print of the required format(s)
from the computer and put the stamp as ‘DOCUMENT CONTROLLED’ using blue
ink, on the top right corner of each page.
7.5.3. if there is no retrieval, NA shall be written under the retrieval and remark column.
7.5.4. If issued formats are retrieved, the retrieval process shall be recorded in Document
Requisition, Modify, obsolete, Request Form No# F01/SOP/QA001 and shall be
destroyed by shredding and shall be updated under remark column.
7.6. Requisition/Issuance/Retrieval of Protocols (Documents and Data Control):
7.6.1. The user department shall send the approved requisition on Document Requisition,
Modify, obsolete, Request Form No# F01/SOP/QA001, as when required to QA
Department.
7.6.2. For issuance of protocols, the authorized QA person shall print a photocopy of the
respective protocols and put the stamp ‘DOCUMENT CONTROLLED’ using blue
ink, on the top right corner of each page.
Requisition, Distribution, and Retrieval of the Documents and Data:
7.6.3. User department shall provide the approved request to QA for executed documents
(Such as Manual, Qualification documents, Executed Batch records, Executed QC
data, etc.) whenever required as per Document Requisition, Modify, obsolete, Request
Form No # F01/SOP/QA001,.
7.6.4. All Document Requisition, Modify, obsolete, Requests shall be recorded in the
Document Requisition, Modify, obsolete, Request logbook Form No#
F02/SOP/QA001, by QA responsible person.
7.6.5. Each department shall submit original documents to QA, the reference documents (like
machine manuals, etc.), and literature cross-referred in preparing the documents like
SOPs, protocols, etc. The document-controlled copy of the master documents shall be
issued to the user department for reference purposes.
7.6.6. The issued and retrieval record shall be maintained.
7.6.7. Additional pages of BMR / BPR shall be issued after receipt of approved requisition
from production.
7.6.8. SOPs may require the annexure which is to be updated frequently e.g. list of
equipment, list of approved vendors as per SOP.
7.6.9. In this case, the annexure shall be updated and controlled, and distributed as per this
SOP. While revising such annexure, it is not required to revise the whole SOP unless
the objective and scope of the SOP gets changed.
Review / Revision of the Documents and Data:

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 4 of 15
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

7.6.10. The SOPs shall be reviewed/ revised follow the direction of “Issue, Review, Approval
and authorization of Standard Operating Procedures” SOP No SOP/QA002 and all
other master documents shall be reviewed within + 30 days of the ‘Review Date’
assigned on the concerned document.
7.7. Periodic Review of logbook:
7.7.1. All the logbooks of equipment/machines logbooks etc. shall be reviewed monthly by
owner department.
7.8. Handling of Records
7.8.1. Each department shall be responsible to fill all the records relevant to the approved
written procedures.
7.8.2. The documented data or records shall be forwarded to the QA department at
appropriate intervals.
7.9. Issuance of documents to inspection team/Customer:
7.9.1. For Onsite Inspection Team:
7.9.1.1. Request for any record by the inspection team shall be communicated by the cross
function audit team to the QA back-up team.
7.9.1.2. The QA back-up team members shall retrieve the correct record, review for
adequacy, completeness and relevance, before passing it over to the cross function
audit team.
7.9.1.3. Original documents/Controlled documents shall be provided to the inspection
team whichever applicable.
7.9.1.4. The cross function audit team members attending to the inspection team shall
ensure that the original records / documents are returned back to the respective
departments.
7.9.2. For Offsite Inspection Team/Customer:
7.9.2.1. Photocopies of records/documents for the inspection team shall be stamped with
"FOR INFORMATION” copy.
7.9.2.2. A list of photocopies of all such records/documents handed over to the inspection
team shall be available with QA for future reference so as to avoid
contradictions/confusion.
7.9.2.3. No original records/documents shall be given as evidence to the offsite Inspection
team for attachments to their audit reports.
7.10. Handling of external documents and data:
7.10.1. If any external origin document like:

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 5 of 15
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

 Pharmacopoeial document,
 Reference books or any type of technical document
7.10.2. Received at the plant shall be stamped by QA authorized person using stamp (External
Document) using blue ink, on the top right corner of the first page and the last page of
the document after review and verification of documents.
7.11. Review and approval of calibration certificates, validation certificate, and
reports:
7.11.1. All the calibration data of equipment/instrument like
 Data of calibration for thermometers, gauges, PLCs, motors, pumps,
 Validation certificate, and reports, etc received from outside party shall be
received and reviewed by the QA Department.
7.12. Storage and Destruction of Documents and Records / Data:
7.12.1. All the documents/data must be kept under lock and key in the control of Quality
Assurance and record shall be maintained.
7.12.2. Authorized QA Person shall prepare a list of records in duplicate and paste one copy
on the box & the second in the file which is placed in the record room.
7.12.3. Place the box on the rack and write the rack no. on the box and on the second copy that
is filed.
7.12.4. The storage arrangements must make reasonable provisions to prevent loss of or
damage to the documents.
7.12.5. The risk factors to be considered when assessing the storage arrangements include fire,
water, environmental conditions, insects, rodents, theft, Accidental destruction,
incorrect filing, easy retrieval, and failure to return from the issue department.
7.12.6. For Regulatory Market,
 The specific requirements apply to batch documentation which must be kept for
one year after the expiry of the batch to which it relates or at least five years
after certification of the batch by the Qualified Person, whichever is the longer.
7.12.7. Destroy the documents by cutting them into small pieces in presence of QA
manager/Designee. The record of destruction shall be maintained by OA.
8. REFERENCES:
8.1. WHO guideline on good manufacturing practices for pharmaceutical products: main
principles.

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 6 of 15
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

Document Requisition, Modify, obsolete, Retrieval Request

Date: ......../ ........./ ............... Ser. #: ...... - ...... / ......

Department: ......................................... Section: ........................................

Document Name: ......................................................................................... Type: ……………………

Document code: .................................. # Current Issue .............................. :

....... New Issue ....... Modify ....... Obsolete

Request type
Retrieval ....... ....... Copy of current issue # of Copies ……….
Reason of Request: (Describe the requirements)
......................................................................................................................................................................
......................................................................................................................................................................
......................................................................................................................................................................
......................................................................................................................................................................
......................................................................................................................................................................
......................................................................................................................................................................
Prepared by: Reviewed by:
Name: ................................................ Name: ................................................
Title: ................................................ Title: ................................................
Sign. /Date: ................................................ Sign. /Date: ................................................
QA Manager Decision:
.........................................................................................................................................................................
.........................................................................................................................................................................
.........................................................................................................................................................................
.............................................. :Signature/ Date
Form No #F01:SOP/QA001

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 7 of 15
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

Document Requisition, Modify, obsolete, Retrieval Logbook

Document Request Doc. Receiving
.Sr Date Document name Department .Serial no .Sign Remarks
code Type # issue date

Form No#F02/SOP/QA001

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 0 of 15
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

Documents Distribution and Withdrawal List

Document Name: .......................................................................................................................

Document Code: ................................... Department/ Section: ...................................
Issue #: ................................... Issue date: ...................................
Revision #: ................................... Revision date: ...................................

DISTRIBUTION WITHDRAWAL & DESTRUCTION

Received &
Copy No. of Copy No. of
.Ser Dept. Name Received by (Sign. /Date) destructed by Date
.No Copies No. Copies
(QA)

Form
No#F03:SOP/QA003

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 1 of 15
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

Documents Master List

................................ :Department/ Section
Departments
Ser. Document Name Code # of copies
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Prepared by: Reviewed by :

Name .................................................. Name ..................................................
Title : .................................................. Title : ..................................................
Sign. /Date : .................................................. Sign. /Date : ..................................................
Dept. # Department Name Dept. # Department Name Dept. # Department Name Dept. # Department Name
1 2 3 4
5 6 7 8
9 10 11 12
Form No # F04:SOP/QA003

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 2 of 15
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

SOPS INDEX
Department: ................................
.Ser Document name Code Issue\Rev. Date Issue / Rev. No Revision Date

1.1.2 Prepared by 1.1.1 Approved by

1.1.6 Name 1.1.5 ....................................
1.1.4 Name 1.1.3 ....................................
1.1.10 Title 1.1.9 ....................................
1.1.8 Title 1.1.7 ....................................
1.1.14 sign. /Date 1.1.13 ....................................
1.1.12 sign. /Date 1.1.11 ....................................

Form No# F03:SOP/QA003

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 0 of 15
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

QA Stamps (Annex 1)

DOCUMENT
ORIGINAL CONTROLLED

FOR INFORMATION Obsolete

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 1 of 15
 Standard Operating Procedure
Title Control of Documents
Department Quality Assurance
SOP NO Issue NO Revision No Issue date Effective Date Review Date
SOP/QA001 01 01 01/01/2024 01/01/2024 01/01/2025

9. Change History

Version No Prepared by Issue Date Description of Changes

MOHAMED
01 01/01/2024 1st Issue
OSAMA

Name Title Sign/ Date

Prepared by Mohamed osama Q.A. SPECIALIST
Reviewed by AHMED ESSAM PRODUCTION MANAGER
Approved by MOHAMED MOSA Q.A. MANAGER
SOP/QA001
Page 2 of 15