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- Raw material work order, Packing material work order, Batch Manufacturing Record and Batch Packing Record are verified before production and then issued to concerned department by QA. All master formulas are in the product manual.
Standard Operating Procedures are made available in Production department. Preparation, Revision and distribution of documents are from Quality Assurance department. Any changes if required, are done with the permission of Plant Manager and Asst. QA Officer.
- All master documents are stored in the record room in QA/QC department.
- All documents are given revision number while revising.
- There are documents for Raw material specifications, Packing material specifications, Finished product specification, Finished product Method of Analysis, Raw material and Packing material Standard Test procedures, Standard Operating Procedures for all departments, Batch Records, Product Manuals, Master validation plan Validation Protocols for equipment validation, cleaning validation, Process validation, Analyst Validation and method validation, Annual product quality review etc.
- Water is analysed periodically for microbiological and chemical tests. Water is analysed after regeneration. Related records and analytical reports are maintained.
- Total microbial counts of different sections are carried out after fumigation periodically.
- All documents related to production are maintained for one year after expiry of the product.
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| Documentation Controls. |
- All documents are kept in record room in Quality Assurance/Quality Control Department. Revisions are made to the documents with due authorization from Plant Manager and Asst. QA Officer. The older documents are sealed as obsolete, filed and kept in record room.
- Batch records contain step-to-step procedure for manufacturing. Any changes are done with the authorization of Plant Manager and Asst. QA Officer. All batch records are issued from QA. A master copy is kept in record room and whenever there is requisition from any department, photocopies of this is made and ‘QA issued’ signature with date is put and issued. Batch records have provisions to incorporate reconciliation of materials and also includes materials rejected online and excess materials returned to stores.
- All Standard Operating Procedures are kept in record room with green coloured seal of ‘MASTER COPY’ on it. Any display copies are photo copies of MASTER COPY with a blue coloured seal of ‘CONTROLLED COPY’. Number of copies issued is documented and maintained. At the time of revision, the old copies are sealed as ‘OBSOLETE’ in red colour and filed and kept in record room.
- Separate documents are generated for QA procedures like deviation control, change control, non-conformance, out of specification, calibration documents, disposal of specific rejected materials etc and these are maintained as per document control SOP.
- All documents, reports, SOP’s have numbering system to assure proper document control.
- Other records maintained are Training Records, Medical Check-up records, Calibration records and Pest / Rodent Control Records.
- All records related to production are stored up to 1 year after expiry of the product.
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