DOCUMENT CONTROL SOP

1.0 PURPOSE :
To provide a procedure for document control.
2.0 SCOPE :
To ensure a complete control over all the authorised documents.
3.0 RESPONSIBILITY :
QA Personnel
4.0 PROCEDURE :
4.1 All documents should be identified by a unique title and document number.
4.2. Document should be designed, prepared, received, approved, signed and dated by authorised persons and distributed to concerned departments.
4.3. Approved documents should not be corrected manually with a pen / pencil for any reason.

Preparation of Documents
4.4 Master Formula Record -
Master formula record to be prepared by QA in consultation with Formulation development, Production and Quality Control.
Master formula record includes :
4.4.1 Batch Manufacturing record (BMR).
4.4.2 Batch Packing record (BPR).
4.4.3 Intermediate/ Packing Material / Finished product specification.
4.4.4 Specimen of Printed packaging material.
4.5 All documents of “ Master Formula Record” should be stamped as “Master Copy” in Green at the non- text side (back side).
4.6 Batch Manufacturing Records consists of following.
4.6.1 Manufacturing Work Order.
4.6.2 Coating Work Order
4.6.3 Stage wise processing details
4.6.4 In-process checks
4.6.4.1 Compression and coating (Tablets)
4.6.5 Deviation (if any)
4.7 Batch Packing Records consists of following.
4.7.1 Packing work order.
4.7.2 Over printing details
4.7.3 Packing details
4.7.4 In-process checks
4.7.4.1 Over printing
4.7.4.2 Bottle washing and filling (liquid orals)
4.7.4.3 Bottle cleaning and filling (Dry Syrup)
4.7.4.4 Packing
4.7.4.5 Shipper weight profile
4.7.5 Deviation record (if any)
Document Issuing
4.8 During the issue of a document the necessary entries have to be made in the respective document control register with details of Document name, Document number, Issued by, received by, Retrieved document No., (if any) Number of copies retrieved, destroyed by, Date, Checked by details.
4.9 BMR / BPR - photo copies of master copy are issued for regular production. All sheets of photo copies should be signed and dated by QA Personnel.
4.10 Completed batch record should come back to QA for review.
4.11 After review of the records and QC analytical results, QA will release the batch (Product) for sale.
4.12 All the completed batch records should be controlled by QA.
4.13 All batch record should be retained atleast for five year after the shelf life of the product.
4.14 Validation protocol / Report / Summary: All validation protocols to be prepared by QA and issued to respective department.
4.15 After completion of validation, the Protocols, Reports along with the QC results and Summary report to be prepared and filed by Q.A. department in respective validation records.
4.16 Protocols and reports of cleaning validation with the QC analytical reports to be prepared and filed in a Cleaning validation file.
4.17 Equipment Qualification: Equipment Qualification protocols / Reports to be issued by QA to the respective department.
4.18 All completed Equipment Qualification Protocol / Reports should be compiled by QA in respective qualification files.
4.18.1 Design Qualification
4.18.2 Installation qualification
4.18.3 Operational qualification
4.18.4 Performance qualification
4.18.5 Visit reports (if any)
4.19 Specifications :
All specifications of Raw material / Packing material / Intermediate / Finished product specification to be prepared by QC and authorised by QA. Original documents should be filed in respective master files of QA Department with a “MASTER COPY” seal in green colour on the text side (backside) of the page.
4.20 A controlled copy of specification should be issued to the QC department with “CONTROLLED COPY” seal in red colour on top of each page on the printed side.
4.21 Standard Operating Procedure :
SOP to be prepared as per the SOP preparation of SOP.
4.22 Master copies of SOP should be filed in QA department in respective files with “MASTER COPY” seal in green colour on the non text side (backside) of the page.
4.23 Different stamps should be used for circulating SOP to the concerned departments either with a “CONTROLLED COPY” seal in red colour or “DISPLAY COPY" in blue colour on top of each page on the printed side as per the need.
4.24 Third party document :
Separate files to be maintained for each third party.
4.25 Batch records for Third parties to be prepared by QA Department according to their requirement.
4.26 Master copy of the records to be filed in respective files and controlled copies should be issued to concerned parties.
4.27 Batch summary sheet and other related documents to be collected by them, reviewed and filed by QA.
4.28 Art works
All documents related to artwork approval including the specimen samples to be filed and controlled by QC and QA department.
4.29
Stability samples
Details of stability samples to be maintained.
4.30
Log Books : Following Log books should be maintained (Annexure – List of log books with numbers)
4.30.1
Production Department
4.30.1.1
Equipment Operation
4.30.1.2
Equipment Cleaning
4.30.1.3
Planned Preventive Maintenance of Equipment
4.30.1.4
Temperature and Humidity
4.30.1.5
Pressure Differential
4.30.1.6
Balance Calibration
4.30.1.7
General House Keeping
4.30.1.8
PestoFlash
4.30.1.9
Issue and control of stereos
4.30.1.10
Issue and control of Punches and dies
4.30.1.11
Intermediate log
4.30.1.12
Overprinting of Packaging Materials
4.30.1.13
pH meter log
4.30.1.14
Transfer pump and Transfer line log
4.30.2
Utility Department
4.30.2.1
DM Plant Operation
4.30.2.2
DM Plant Regeneration
4.30.2.3
Planned Preventive Maintenance of AHUs
4.30.2.4
Compressed Air
4.30.3
Quality Control Department
4.30.3.1
Instrument Operation and cleaning
4.30.3.2
Volumetric Solutions
4.30.3.3
Reference Standard
4.30.3.4
Working Standards
4.30.3.5
Reserve Sample
4.30.3.6
Control Sample
4.30.3.7
Glass ware calibration
4.30.3.8
Calculation sheet
4.30.3.9
pH meter
4.30.3.10
Distilled water log
4.30.3.11
Autoclave Calibration
4.30.3.12
Sub culturing and destruction of sub culture
4.30.3.13
Media Stock Register
4.30.3.14
De-fumigation checks log
4.30.3.15
Media Preparation
4.30.3.16
Media destruction
4.30.3.17
Growth Promotion test
4.30.3.18
Plate exposure
4.30.3.19
UV lamp log
4.30.3.20
Raw materials analysis
4.31
Training record : The training records of individual personnel, should be retained till the last record which has to be signed by him expires.
Training Records consists of
4.31.1
Annual training Schedule
4.31.2
Training modules
4.31.3
Individual Training records
4.31.4
General Training record
4.31.5
Material/Visual aids/Literature used for Training
4.32
Apart from the above documents, QA Department should also maintain the following records.
4.32.1
Technical Change Procedure
4.32.2
Audit report
4.32.3
Fumigation record
4.32.4
Packing specification
4.32.5
Monthly report
4.32.6
Annual report
4.32.7
Training record- Schedule and individual training files
4.32.8
Medical checkup record
4.32.9
Pest control record
4.32.10
Market complaint
4.32.11
Instrument calibration(External agency)
4.32.12
Batch Record Register
4.32.13
Validation Register (Cleaning, Process and Method)
4.32.14
Change control
4.32.15
Deviation
4.32.16
Out of specification records
4.33
Document Retrieval
A revised document will be issued only after retrieval of the superceded Control copy and Display copy from concerned department. The superceded Master Copy will be retained with the "OBSOLETE COPY" stamp in black colour for future reference and other copies (Controlled and Display copy) will be destroyed.
A record of issue of documents and retrieval and destruction of the superceded documents will be maintained.
Retention of Documents
4.34
All documents should be retained for at least one year after the expiry of finished products.