DOCUMENT AND DATA

CONTROL
Definitions

 Documents - Controlled Quality documents like BMR, SOPs,

Specifications & STPs/ GTPs, Protocols, etc.
 Master Copy - The original set of controlled documents or
written procedures which shall be retained at Documentation
Cell of Quality Assurance and shall always possess the stamp
‘MASTER COPY’ on the front side of every page.
 Controlled Copy - The photocopy of the master copy of
controlled documents (like SOPs, STPs, GTPs etc.) or written
procedures which shall be distributed to the user department(s).
 Uncontrolled Copy - The photocopy of master copy of
controlled documents or written procedures which shall be
given to any department or person for reference purpose only.
 QMS Documents

Quality Manual Master Documents Records

Primary records Secondary records / Sundry records /

(original raw data) documents documents
Generation of the document

User shall prepare documents or make data entry in

records by considering following points:
– Be sensitive to GMP compliance.
– Record activity immediately but correctly.
– Check entry of records for accuracy.
– Sign and date immediately on record.
– Check if deviation exists.
– Don’t destroy record/ evidence in case of deviation or
OOS.
– Co-operation during investigation.
Generation of the document

Checker/ Reviewer shall check/ review the documents

by considering following points:
– Verify record for adequacy/ accuracy.
– Check technique/ skill of user periodically.
– Sign and date for review.
– Report investigation, deviation, incident etc. promptly.
– Advise how to rectify/ correct the error in data entry.
– Guide user in technique & skill.
Generation of the document

Approver shall approve the document by

considering following points:
– Verify adequacy/ accuracy/ sensitivity of
document.
– Verify against guidelines/ regular standards/
SOPs/ Pharmacopoeia.
– Sign and date on approval of document.
– Guide / Assist in investigation.
Generation of the document
 Master copy shall be an approved original copy of
documents and shall be prepared by stamping of “MASTER
COPY” stamp in “Green color” on each page of the document
at right side of top corner position without obscuring any text.
 Controlled copy shall be prepared by photocopy of master
copy with stamping of “CONTROLLED COPY” stamp in “blue
colour”, QA personnel shall write copy no. with sign& date on
each page of the document at bottom right side position
without obscuring any text.
 Uncontrolled copy shall be prepared by photocopy of master
copy with stamping of "UNCONTROLLED COPY" in "red
colour" and signed / dated by QA on each page of the
document at center on the text matter.
Issuance & Control of Documents

 All documents including validation documents like

validation protocols/ reports, qualification
documents, etc. shall be under the control of
Documentation Cell of Quality Assurance
department.
 Documents like SMF, VMP, Quality Policy and
Quality Manual shall be kept at the Documentation
Cell of QA.
 All the Calibration data of equipment / instruments
shall be kept / maintained by the QA department .
Issuance & Control of Documents

 All the data maintained in laboratory software /

production PLCs shall be password protected.
 A printed hard copy of analytical & processing data,
duly signed by operator shall be preserved along
with the respective documents .
 Backup data shall be taken on the compact discs or
space access given by IT personnel by time to time.
 All rubber stamps shall be kept under Lock and Key,
along with updated list of stamps.
Issuance & Control of Documents

 Issuance of all the controlled document shall

be governed by QA documentation cell.
 For issuance of any type of controlled
document, user shall fill the issuance form.
Review and/or Revision of the
Documents

Revision procedure of documents shall be of two type:

– Routine or periodic revision
– Provisional or conditional revision
All the controlled documents shall be reviewed within one
month before and after the ‘Review Date’ assigned on the
concerned document.

If there is a need of any change in a document, the revision shall be

initiated by only “change control form” as given in the SOP on
change control.
 Review and/or Revision of
the Documents
QA shall intimate the initiator department to initiate review process

Initiator department shall undertake the review

Initiator department shall forward the Document Review Form with

comments to QA
On receipt of the final comment from the concerned dept, QA shall
dispose the review process.
Quality Assurance shall assess the proposed changes. If OK, approved.
QA shall forward the approved draft copy to initiator department to
prepare a final soft copy of document.
By incorporating all comments on soft copy, initiator shall forward it to QA.
Initiator shall delete the same from his/her computer and E-mail.
QA shall take out the final print out.
Revised copy of document shall be signed by concerned persons,
approved by Q.A. Head.
Distribution and Retrieval of the
Documents

 All the controlled documents shall be distributed and

retrieved by Documentation Cell of QA.
 Distribution and retrieval of the concerned document
shall be done using the specially prepared form titled
‘Document Distribution and Retrieval Record’.
 Additional controlled and / or uncontrolled copies of
the documents, if required, shall be requested
through a form titled ‘Requisition for Additional copy’.
 The retrieved controlled copies of the document shall
be destroyed by Documentation Cell of QA.
Archiving of Documents

 Arrangement of all the documents shall be with

respective department wise that can be identity and
easily traceable.
 All the batch records received should be reviewed
and then store in designated area according to the
Batch No.
 The master copy of superseded document shall be
retained by the Q.A. and stamped as “OBSOLETE”
in center of document on every page.
Retention of documents

S. Method of
No Type of Document Retention Period
Destruction

Cleaning and maintenance After one year of product expiry Shredding

1 documents

2 Calibration record 3 years Shredding

3 Packaging material record After one year of product expiry Shredding

4 Batch Manufacturing record After one year of product expiry Shredding

5 Qualification record Permanent Not to be destroyed

6 Validation record Permanent Not to be destroyed

7 Cleaning Validation record Permanent Not to be destroyed

8 Water system Validation record Permanent Not to be destroyed

Retention of documents
S. Method of
Type of Document Retention Period
No Destruction

9 Media fill record Permanent Not to be destroyed

10 Method Validation record Permanent Not to be destroyed

11 Validation master plan Permanent Not to be destroyed

12 Site Master File Permanent Not to be destroyed

13 Master formula record Permanent Not to be destroyed

14 Vendor audit report Permanent Not to be destroyed

15 Department manuals Permanent Not to be destroyed

16 Standard operating procedures 10 year Not to be destroyed

17 Training record 1 Year after resignation of employee Shredding

18 Internal audit record 5 years Shredding
19 Medical records 1 Year after resignation of employee Shredding
Retention of documents
S. Method of
Type of Document Retention Period
No Destruction
20 Controlled copies of Master Destruction on retrieval Shredding
Documents
Stability Data Permanent Not to be destroyed
21

Organogram Permanent Not to be destroyed

22

Specification, STP, GTPs Permanent Not to be destroyed

23

Facility layouts Permanent Not to be destroyed

24

Filled formats & records 5 years Shredding

25
Handling of Records

 Each concerned department shall be

responsible to fill all the records relevant to
the approved written procedures.
 The documented data or records shall be
forwarded to Documentation Cell of QA at
appropriate intervals.
 Documentation Cell of QA shall prepare a
department wise list of records.
Destruction of Documents and
Records

 Retrieved controlled copies of superseded

documents shall be destroyed by Documentation
Cell of QA using paper shredder machine or
manually or through incineration and the relevant
recording shall be done.
 Incharge, Documentation Cell of QA or his/ her
designee shall record the details of destruction of
obsolete master copies/ documents in
‘Documents/Data Destruction Record’
Handling of External Origin Documents

 External origin documents such as pharmacopeias,

books, reference guideline etc. shall be issued,
retrieved and controlled by QA.
 Issuance record of these documents shall be
maintained by QA.
 In case new versions of these documents shall be
published then QA shall procure these new versions
of documents.
 QA personnel shall retrieved the old version of these
documents.
THANK YOU!