QA & QC

MICROBIOLOGICAL CONTROL FOR EXCIPIENTS, DRUG PRODUCT AND DRUG SUBSTANCE PURPOSE: To describe microbiological test controls to be applied for outsourced and in house drug substances, drug products and excipients. SCOPE: This SOP is applicable to drug substances, drug product, sterile drug product and excipients tested for microbiological quality. RESPONSIBILITY: Microbiologist …

MANAGEMENT OF RAW DATA PURPOSE: To provide a procedure for recording, review and storage of raw data at manufacturing sites. SCOPE: This SOP applies to all the raw data generated / collected during Warehousing, manufacturing/packaging operations, testing, environmental monitoring, operation and monitoring of equipment and utilities, calibrations, qualification and validation activities, cleaning, …

STORAGE AND DISPOSAL OF EXHIBIT BATCHES OF DRUG PRODUCTS PURPOSE: To describe a procedure for Storage and Disposal of Exhibit Batches of Drug Products. SCOPE: This standard operating procedure (SOP) is applicable to the exhibit batches of Drug Products manufactured and packed in the formulation manufacturing facilities. RESPONSIBILITY: Production: Transfers …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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. …

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: …

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. …

VALIDATION: PROCEDURE FOR AGREEMENT/QUALIFICATION OF EXTERNAL VALIDATION AGENCIES/SERVICES PROVIDERS/PARTIES The purpose of this SOP is to lay down procedure for selection Qualification and approval of Service Providers for Outsourced activities of manufacturing sites  This procedure shall be applicable for approving, controlling and reviewing of Service Providers supporting outsourced activities relevant …

INVESTIGATIONS SOP  This Standard Operating Procedure (SOP) defines the requirements for reporting, documenting, investigating, evaluating, managing, resolving and approving closure of investigations from cGxP, approved specifications and/or procedures. This standard applies to Investigations related to quality related events that occur from cGxP, approved specifications, and/or procedures including but not limited …

SOP ON ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT To lay down a procedure for establishment of Alert Limit and Action Limit. ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT OF SCOPE This SOP is applicable to critical stages of system, analytical test / Microbial test, on-line result regarding water system, …

QUALIFICATION OF CONTRACT TESTING LABORATORY The purpose of this SOP is to describe the procedure for selection, approval, renewal of contract testing laboratory for testing / calibrations. SCOPE OF CONTRACT TESTING LABORATORY: This procedure is applicable for testing done at contract testing laboratory for raw material, intermediate, packaging material, finished …

HANDLING OF ISOLATES This procedure elaborates the systematic approach for the isolation and identification of organism from the routine microbiological testing and monitoring followed by Preparation of cryo vials for isolates. SCOPE HANDLING OF ISOLATES : This SOP is applicable for the characterization of the environmental isolates, Water isolates / product isolates …