Operation and Cleaning of Refrigerator Objective: To lay down a procedure for the Operation and Cleaning of the Refrigerator in the Raw Material Store. Scope: This Standard Operating Procedure is applicable for the operation and cleaning of the Refrigerator in the Raw Material Store at the formulation plant. Responsibility Raw material Store personnel shall be…
Cleaning of SS Trolleys, Pallets and Racks Objective: To lay down a procedure for cleaning SS Trolleys, Pallets, and Racks Scope: This SOP is applicable for cleaning SS Trolleys, Pallets, and Racks in the Raw Material Store/packing material/finished goods at the formulation plant. Responsibility Store personnel shall be responsible for following the procedure mentioned in…
SYSTEM MAINTENANCE PROCEDURE FOR STABILITY CHAMBER GENERAL MAINTENANCE ONLY TRAINED AND SKILLED PERSONS SHOULD MAINTAIN THE MACHINE. Follow work permit procedure before any maintenance work. Thermolab will not be responsible if the same is ignored. Check whether the stability chamber is clean from inside and outside after use. Check the humidity tank, kettle heater and…
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Housekeeping OBJECTIVE: To lay down a standard operating procedure for Housekeeping in the factory. SCOPE: This SOP is applicable for Housekeeping. RESPONSIBILITY: Officer/ Executive – HR ACCOUNTABILITY: Manager/ Head- QA / All Concerned HOD PROCEDURE: CLEANING TOOLS: Mops, Wiper, Glass wiper, Glass cleaner and Vacuum Cleaner and plastic broom shall be used for cleaning. PREPARATION OF DISINFECTANTS AND…
PROCEDURE FOR HANDLING OF EXTERNAL AUDITS OBJECTIVE: The purpose of this SOP is to lay down the procedure for handling of external inspections / audits by the agencies and customers for various products. SCOPE: This procedure is applicable for handling of external inspections / audits. RESPONSIBILITY: Site Head: To welcome auditors at opening meeting. To…
HANDLING OF BIOHAZARDOUS MATERIAL IN MICROBIOLOGY LAB PURPOSE: To outline the procedure for Handling Biohazardous Material in the Microbiology Lab. SCOPE: This procedure is applicable for Handling Biohazardous Material in the Microbiology Lab. REFERENCE(S) & ATTACHMENTS REFERENCES In-House ISO 45001:2018 CROSS-REFERENCE DOCUMENTS Preparation, Review, Approval, Issuance & Retrieval of Standard Operating Procedures (SOPs) Change Control…
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HANDLING OF AUDIT TRAIL PURPOSE: This SOP describes the procedure for Handling of system audit trail/ Batch audit trail report which is generated by the manufacturing, packing, warehouse and utility equipment. SCOPE: This SOP is applicable to all manufacturing, packing, warehouse and utility equipment. RESPONSIBILITY: User Department: To prepare procedure for review of system audit…
COMPUTERIZED SYSTEM LIFE CYCLE PURPOSE: The purpose of this procedure is to define the system life cycle methodology that shall be used while implementing GxP computerized system to ensure that system remains in state of validation throughout the system life cycle. SCOPE: This SOP is applicable for all GxP computerized system at all the manufacturing…
HANDLING OF DATA INTEGRITY AUDIT OBSERVATIONS
AUDIT POINT Warehouse: Pictorial presentation not available in sampling change room (Minor) Manufacturer released /approved label not defaced (Minor) Policy for usage of raw materials having retest date claim by manufacturer not defined in in SOP (Minor) Dispensing scoop status label not available of cleaned on, previous product, Use up to Most of the tools…
VERIFICATION AND TESTING OF FINISHED GOODS PURPOSE: To provide the procedure for testing of finished Goods at outside laboratory and physical verification to ensure that product is complies with specification criteria. SCOPE: This Procedure is applicable for finished product testing at outside lab and receive at depot. Procedure for Physical verification of finished product is…
SHELF LIFE EXTENSION OF EXISTING COMMERCIALIZED PRODUCTS PURPOSE: To define a procedure for shelf life extension of existing commercialized products. SCOPE: This procedure shall be applicable for shelf life extension of existing commercialized products which comprises volumes of Domestic market. RESPONSIBILITY: Site Quality Assurance To provide stability study data for review/evaluation. To provide stability sample/control…
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HANDLING OF PHARMACOPOEIAL CHANGES PURPOSE: To lay down a procedure for the handling of Pharmacopoeia changes. SCOPE: This procedure shall be applicable for Assessment and Implementation of Pharmacopoeia changes in API, Excipient and Drug products those are handled when appearing in the official Pharmacopoeia like IP, BP,USP and Ph. Eur. etc. This procedure is applicable…
In-process checks during Dry powder injection manufacturing & packing (IPQA) Objective: : To lay down a procedure for in process checks during Dry powder injection manufacturing & packing. Scope: This procedure is applicable to formulation Plant of pharmaceutical Industry for in process checks during Dry powder injection manufacturing & packing. Responsibility: IPQA Officer/Executive shall be responsible…
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Liquid Bourne Particle counter (LBPC) Objective: To lay down the procedure for Cleaning, Operation, Maintenance, and Analysis of samples using LBP counter. Scope: This SOP is applicable for the Operation, Cleaning, Maintenance and Analysis of LBPC samples in the manufacturing department. Responsibility: Microbiologist / IPQA personnel are responsible for follow the procedure. Accountability: Head – Quality Assurance…
Cartridge filter Integrity Testing SOP Objective: To lay down a procedure for integrity testing of the cartridge filter. Scope: This SOP is applicable for integrity testing of cartridge filters in the formulation plant. Responsibility: Production officer / Executive Accountability: The production Head shall be accountable for compliance with SOP. Procedure Pre-Start-up Close the air vent of…
Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -9 Question 1: What is robustness, and when should its evaluation be considered? Answer 1: Robustness is the measure of an analytical procedure’s reliability with respect to deliberate variations in method parameters. Its evaluation should be considered during the development phase of the procedure….
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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -8 Question 1: What validation approach can be used to validate an estimated value for the detection limit? Answer 1: An estimated value for the detection limit can be validated by the independent analysis of a suitable number of samples known to be near…
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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -7 Question 1: What are the possible approaches for determining the detection limit, and what determines their applicability? Answer 1: The possible approaches for determining the detection limit depend on whether the procedure is non-instrumental or instrumental. Approaches include visual evaluation and signal-to-noise determination….
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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -6 Question 1: How should accuracy be assessed in the quantitation of impurities? Answer 1: Accuracy should be assessed on samples (drug substance/drug product) spiked with known amounts of impurities. Question 2: What is considered acceptable when it is impossible to obtain samples of…
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