Amended Schedule M makes it mandatory that the following records will have to be maintained to establish compliance.
" Records for validation of system for treatment of water to render it potable.
" Records to be maintained for all disposal of waste.
" Written duties of technical and quality control personnel to be laid down.
" Written instructions that all Technical Personnel in Production and Quality Control to receive training.
" Medical examination records for Health, Clothing and sanitation of workers.
" Records for testing products (not prepared under Aseptic conditions) for absence of pathogen.
" Records of S.O.P.s for Air handling system, Pressure differential Segretation status and labelling and cleaning,
" Adequate records of maintenance and service for processing drugs like B-Lactum, Antibiotics, Sex Hormones, Cytotoxic substances.
" Line Clearance records.
" Authorisation in writing of correct detailed printing on packaging materials.
" Records of maintaining of manufacturing environment at required levels of temperature, humidity and cleanliness,
" Records and S.O.P.s for routine Sanitation Programme to be drawn for compliance.
" Inventory of raw materials to be used in Manufactures and for maintaining records as per Schedule-M.
" Records for checking integrity of packages of
" raw materials.
" Records for damaged containers to be identified and segregated.
" S.O.P.s for sampling,testing and reuse.
" Records of issue of labels for appropriate labelling of Raw Materials.
" Records of controlled temperature and humidity for raw materials to be kept in cool place or cold place.
" Providing logbook for each equipment.
" Records for calibration of each equipment and preparing S.O.P for checking on schedule basis.
" Documentation and records under para 12 which includes designing and preparation of documents, approval of documents, specify title, nature and purpose, Review of documents at regular interval.etc.
" Records to be completed at the time of each manufacturing operation.
" Records of receipt of all labelling and packing materials for each shipment.
" Quality assurance - System to be adopted and recorded to ensure various requirements under para 14.1.
" Self Inspection and Quality Audit records by constituted Team of independent, experienced and qualified persons.
" Preparation of written instructions for self-inspection.
" Quality Control System- S.O.P to be prepared and adopted for
-Sampling
-Specifications
-Testing
-Documentation
-Release procedure
-Monitoring environment.
" Documentation records to be prepared by Q.C Dept. for authorisation and detailed specification for-
1) All materials
2) Reagents
3) Solvents
4) Water
" Records and certification for Testing Batch of product and its release.
" Records for keeping Reference Samples and their final disposal S.O.P for this purpose.
" Assessment records pertaining to finished products.
" Records of Stability Studies of products.
" Complaint investigation records.
" Specification records for -
1) Raw material, packaging material;
2) For product containers and closures;
3) For finished products.
" Master formulae records.
" Packaging records.
" Batch packaging records.
" Batch Processing records.
" Preparation of S.O.P.s for -
(1) Receipt of raw material
(2) Sampling
(3) Batch numbering
(4) Testing
(5) Records of Analysis.
" Reference Samples for Active Ingredients and finished product, giving storage conditions, expiry date and date of disposal.
" Various procedures duly approved and validated for reprocessing and recoveries.
" Distribution records.
" Preparation of pre-determined protocols to be prepared for validation.
" Written document summarising recorded results and conclusions in respect of particular validation.
" Records for critical process validation to demonstrate that the process remain capable of achieving intended results.
" Records for defining process using material and equipment to yield product consistently of the required quality when new Master formulae in method of manufacturing is adopted.
" Records for validation.
" Written procedure in Form-9. S.O.P. for recall of products.
" Records for investigation
" of complaints and adverse reaction.
" Document in Form-9. Site Master File.
" Additional records to be maintained for Manu-facture of -
(1) Sterile products
(2) For maintenance of oral solid dosage form;
(3) For oral liquids and Topical products close inhales, and for Bulk Drugs.
(Courtesy: IDMA Bulletin)