procedure for document control system

1.0 Objective
1.1 To lay down a procedure for document control system.
2.0 Scope
2.1 This SOP is applicable for Document Control System at abc Company.
3.0 Responsibilities
3.1 Officer Quality Assurance
3.2 Executive Quality Assurance
4.0 Accountability
4.1 Head-QA
5.0 Procedure
5.1 All documents should be identified by a unique title and document number.
5.2 Documents should be prepared, reviewed, approved, signed and dated by authorized persons and

distributed to concerned departments.
5.3 Approved documents should not be corrected manually with a pen/ pencil for any reason.
5.4 Follow the procedure for document control as laid down for different documents.
5.5 Master Formula record-Master files to be prepared by QA in consultation with Production and

Quality Control. Master file includes:
5.5.1 Batch Manufacturing record (BMR).
5.5.2 Intermediate/Packing Material/ Finished product specification.
5.5.3 Specimen of Printed packaging material.
5.5.4 All documents of should be stamped a ‘Master Copy” in Red Ink at the top middle on front.
5.6 Batch Manufacturing Records consists of following:
5.6.1 Manufacturing raw material requisition.
5.6.2 Stage wise processing details
5.6.3 Rinse/Swab water intimation Slip.
5.6.4 In-process checks
5.6.5 Filling
5.6.6 Packaging material requisition
5.6.7 Over printing details
5.6.8 Packing details
5.6.9 In-process checks
5.6.10 Shipper weight profile
5.7 Document Issuing
5.7.1 Register with details as per relevant annexure.
5.7.2 BMR-photo copies of mater copy are issued for regular production. All sheets of photo copies should

be stamped of controlled copy issued by signed and dated by QA Personnel.
5.7.3 Completed batch record shall be review by QA before release the batch.
5.7.4 After review of the records and QC analytical result, QA will release the batch (Product0 for sale.
5.7.5 All the completed batch records by be persevered in control of Quality Assurance department.
5.8 Validation protocol/ Report/ Summary All validation protocols t b prepared by QA with consultation

of production, QC, Engineering & other departments and issue he same to respective department to

performed the validation activity.
5.8.1 After completion f validation the protocols, epos along with the QC results and summary report to be

filled by QA department in respective validation records.
5.8.2 Protocols and reports of cleaning validation with the QC analytical repots to be filled in a

cleaning validation file.
5.9 Equipment Qualification: Equipment’s qualification protocols/ reports to be issued by QA to the

respective departments.
5.9.1 All completed equipment qualification protocol/ repots should be compiled by QA in respective qualification files.
5.10 Specifications: All specifications of raw material/packing material/ intermediate/ finished product

to be prepared by QC and authorized by QA. Original document should be filled in respective master files

of QA department with a “MASTER COPY” stamp in Red color at top of each page.
5.11 A controlled copy of specification should be issued the QC department with “CONTOLLED COPY”
Seal in Green color on right Top of each page on the printed side.
5.12 Standard Operating Procedure: SOP to be prepared as per the SOP on SOP.
5.12.1 Master copies of SOP should be filled in QA department in respective files with “MATER
COPY” stamp in Red color at the middle top of each page.
5.13 Artworks: All documents related to artwork approval including the specimen samples to be filled and controlled By QA department.
5.14 Stability samples: Details of stability samples with the protocols to be maintained and filled by
QA department.
5.15 Log Books: Following Log books should be maintained:
5.15.1 Production department
5.15.1.1 Equipment Operation
5.15.1.2 Planned Preventive Maintenance of Equipment
5.15.1.3 Temperature and Humidity
5.15.1.4 Pressure Differential
5.15.1.5 Balance Calibration
5.15.1.6 General House keeping
5.15.1.7 Pesto Flash
5.15.1.8 Issue and control of stereos
5.15.1.9 Issue and control of punches and dies
5.15.1.10 Intermediate log
5.15.1.11 Overprinting of Packaging Material
5.15.2 Engineering Department
5.15.2.1 Purified water plant operation
5.15.2.2 Purified water plant Regeneration
5.15.2.3 Preventive Maintenance
5.15.2.4 Compressed Air
5.15.3 Quality Control Department:
5.15.3.1 Reference Standard
5.15.3.2 Working Standards
5.15.3.3 Reserve Samples of raw material
5.15.3.4 Glass ware calibration
5.15.3.5 Instrument calibration record
5.15.3.6 Instrument usage &cleaning record
5.15.3.7 Autoclave Calibration
5.15.3.8 Sub culturing and destruction of sub culture
5.15.3.9 Media Stock Register
5.15.3.10 Media destruction
5.15.3.11 Fumigation record
5.15.3.12 Growth Promotion test
5.15.3.13 Plate exposure
5.15.3.14 UV lamp Log
5.15.3.15 Raw materials analysis record
5.15.3.16 Instrument Operation and cleaning Volumetric Solutions
5.16 Training record: The training records of individual personnelshould be retainedtill the last record
which has to be signed by him expires. Training records consists of:
5.16.1 Annual training Schedule
5.16.2 Material/Visual aids/ Literature used for Training
5.17 Apart from the above documents, QA Department should also maintain the following records:
5.17.1 Audit report
5.17.2 Packing specification
5.17.3 Monthly report
5.17.4 Annual report
5.17.5 Training record- schedule and individual training files
5.17.6 Market complaint
5.17.7 Instrument calibration (External agency)
5.17.8 Batch Record Register
5.17.9 Validation register (Cleaning, Process and Method)
5.17.10 Change control
5.17.11 Deviation
5.17.12 Out of specification records
5.17.13 Document Retrieval
5.17.14 A revised document will be issued only after retrieval of the superseded control copy and from

concerned department. The obsolete Master Copy will be retained with the “OBSOLETE COPY”

stamp at middle of each page in Red color for future reference and other copies Controlled will be destroyed.
5.17.15 Record of issue of documents and retrieval and destruction of the superseded documents will be maintained.
5.17.16 Attention of documents: Documentations should be stored as per relevant SOP for specified period.
5.18 Human resources management department shall maintain record for pest & rodent control,
medical checkup of employees, cleaning & sanitization of plant etc.

Annexure

Sr. No.	Annexure	Title
1	Annexure I	Distribution Record of Controlled SOP’s
2	Annexure II	Distribution Record of Controlled Specifications & STP’s
3	Annexure III	Distribution record of Other Controlled Documents/Format

References

Sr. No.	Reference	Reference Code
1	Current Good Manufacturing Practices (WHO cGMP guidelines)	cGMP

8.0 Abbreviations
SOP : Standard Operating Procedure
CC No. : Change Control Number
cGMP : Current Good Manufacturing Practice
QA : Quality Assurance

Distribution List:

Sr. No.	Dept/Distributed to	Copy No.
1.	Head of Department- Quality Assurance	Master Copy
2.	Office- Quality Assurance	1
3.	Head of department- Quality Control	1
4.	Head of department- Production	1
5.	Head of department- Store	1
6.	Head of department- Engineering	1
7.	Head of department- Personnel & Administration	1