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: …

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 …

COMPRESSED AIR SYSTEM The main aim of the system is to produce and provide the desired quality compressed air as per the designed capacity at designed pressure. The Compressed Air System and quality of the compressed air distributed to all user points must comply with ISO8573, USP, BP and in-house …

PROCEDURE FOR CLEANING, OPERATION AND CALIBRATION OF MICROMETER SCREW GAUGE To lay down a procedure for Operation and calibration of micrometer screw. This procedure is applicable for Operation and calibration of micrometer screw. MICROMETER SCREW GAUGE : A Micrometer is a measuring device used for taking the exact measurement of an …

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 …

Premises, Equipment & Finishing of sterile products as per WHO TRS 961-Annex 6  It is highly recommended that all premises are designed in a way that minimizes the unnecessary entry of supervisory or control personnel. Specifically, Grade A and B areas should be constructed in a manner that allows for …

Operational qualification Documented verification that the system or subsystem operates as intended overall anticipated operating ranges as per WHO TRS 1019-annex3. The OQ should furnish documented proof that utilities, systems, or equipment are functioning in compliance with operational specifications. The tests should be formulated to exhibit satisfactory performance within the …

Design of HVAC systems and components Proper design and management of HVAC systems is crucial throughout their entire life cycle. It is important to maintain documentation, such as schematic drawings, to accurately reflect the current state of the system. To ensure the safety and effectiveness of HVAC systems, risk management …

GOOD MICROBIOLOGY LABORATORY PRACTICES To provide general guidance on Good laboratory practices in microbiology laboratory consisting of activities that depend on several principles, aseptic techniques, control of media, control of test strains, and control of equipment’s, personnel hygiene, health and garments. SCOPE GOOD MICROBIOLOGY LABORATORY PRACTICES: This SOP is applicable …

PERSONNEL TRAINING, QUALIFICATION, MONITORING AS PER USFDA GUIDELINE Personnel Training A well-designed, maintained, and operated aseptic process minimizes personnel intervention. As operator activities increase in an aseptic processing operation, the risk to finished product sterility also increases. To ensure the maintenance of product sterility, operators involved in aseptic activities must …