1.0 PURPOSE
To lay down the procedure for documentation control.
2.0 SCOPE
2.1 This SOP is applicable for control of documents, approved by Quality Assurance (QA).
3.0 RESPONSIBILITY
3.1 In charge-Document Cell
4.0 ACCOUNTABILITY
4.1 Manager – QA & RA
5.0 PROCEDURE
5.1 Area of document control
5.1.1 To execute the approved and current written instructions and policies.
5.1.2 To record the data of operations in approved format.
5.1.3 To control the usage of formats through controlled issuance.
5.1.4 To control the storage, revision, distribution and destruction of documents.
5.2 List of documents
5.2.1 Written Procedures / Policies
a) Standard Operating Procedure (SOP)
b) Standard Test Procedure (STP) / General Test Procedure (GTP)
c) Master Production and Control Record (MPCR)
d) Batch Production and Control Record (BPCR)
e) Qualification and Validation documents
f) Validation Master Plan (VMP)
g) Site Master File (SMF)
h) Quality Policy
i) Stability protocol
5.2.2 Specifications of Raw material, Packaging Material, Inprocess, Intermediate and finished Product.
5.2.3 Drawings
5.2.4 Any other documents as per the requirement.
5.3 Documents shall be prepared and approved as per their respective SOPs.
5.4 MASTER COPY of document (s) shall be archived in Documentation Cell.
5.5 Distribution of Written procedures/policies and specifications
5.5.1 QA shall distribute the written procedures/policies and specifications to the concerned department as controlled copy.
5.5.2 QA shall maintain the record of distribution.
5.6 Issuance of Formats
5.6.1 Formats for recording shall be issued by QA on request from the respective department as per the format xxxxx as loose sheets or in the form of bound book.
5.6.2 If the formats are issued in loose sheets required number shall be photocopied.
5.6.3 Format issuance shall be recorded department wise with unique issue reference number.
5.6.4 Issued loose format shall be stamped with “ISSUED BY QA” stamp along with initial of QA personnel and date.
5.6.5 Before issuance of bound book, QA shall ensure that all pages are matching with approved format.
5.6.6 All pages of bound book shall be numbered.
5.6.7 QA personnel shall write the issuance details in the front page of book as per the format given in xxxxx
5.6.8 QA shall record the issuance of format in issue record as given in xxxxx
5.7 Archival of documents
5.7.1 QA department shall have a document storage facility to archive the following documents:
5.7.1.1 Master copy and Documentation cell copy of all documents mentioned in the section 5.2.
5.7.1.2 Executed BPCR along with QC test records
5.7.1.3 Qualification and Validation documents
5.7.1.4 Stability study protocol/schedule
5.7.1.5 Trend reports & Annual Product Review
5.7.1.6 Obsolete Documents
5.7.1.7 Dispatch records
5.7.1.8 Any other documents as per the requirement
5.7.2 All Departments shall have a document storage facility to archive the executed logs and related documents.
5.8 Revision of Documents
5.8.1 Documents shall be reviewed at the scheduled period or as and when it is needed.
5.8.2 Document shall be revised as per their respective SOPs.
5.9 Destruction of documents:
5.9.1 Executed documents shall be destroyed by shredding or by incineration after 1 year of product expiry period or after 5 years which ever is more.
5.9.2 The following documents shall not be destroyed.
5.9.2.1 Obsolete and current documents.
5.9.2.2 Executed document, which are submitted to regulatory authorities.
5.9.2.3 Qualification and Validation documents.
5.9.2.4 Stability documents.
END OF DOCUMENT
Documentation control, quality assurance, documentation cell
