MANAGEMENT OF RAW DATA
MANAGEMENT OF RAW DATA PURPOSE:To provide a procedure for recording, review and storage of raw …
STORAGE AND DISPOSAL OF EXHIBIT BATCHES OF DRUG PRODUCTS
PROCEDURE FOR HANDLING OF EXTERNAL AUDITS
VIRTUAL INSPECTION
Cartridge filter -Integrity testing of SOP on
Cartridge filter -Integrity Testing SOP Objective: To lay down a procedure for integrity testing of …
MICROMETER SCREW GAUGE
PROCESS VALIDATION PROTOCOL OF TACROLIMUS CAPSULES
Production and Process Controls
CIP -Cleaning In Place
SYSTEM MAINTENANCE PROCEDURE FOR STABILITY CHAMBER
SYSTEM MAINTENANCE PROCEDURE FOR STABILITY CHAMBER GENERAL MAINTENANCE ONLY TRAINED AND SKILLED PERSONS SHOULD MAINTAIN …
HANDLING OF AUDIT TRAIL
COMPUTERIZED SYSTEM LIFE CYCLE
SHELF LIFE EXTENSION OF EXISTING COMMERCIALIZED PRODUCTS
HANDLING OF PHARMACOPOEIAL CHANGES
Recent Posts
March, 2024
19 March
HANDLING OF BIOHAZARDOUS MATERIAL IN MICROBIOLOGY LAB
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 …
7 March
HANDLING OF AUDIT TRAIL
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 …
7 March
COMPUTERIZED SYSTEM LIFE CYCLE
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 …
7 March
VIRTUAL INSPECTION
VIRTUAL INSPECTION PURPOSE: To lay down the procedure for establishing a comprehensive system of virtual inspection in order to determine the effectiveness of the systems, system compliance and to identify the opportunities for continual improvement as per current regulatory requirements. SCOPE: This SOP is applicable for conducting virtual inspection of …
4 March
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 …
