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 for review of system audit … Read more

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 system at all the manufacturing … Read more

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 all Manufacturing/Analytical sites of Vendors, … Read more

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 … Read more

VERIFICATION AND TESTING OF FINISHED GOODS

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 … Read more

SHELF LIFE EXTENSION OF EXISTING COMMERCIALIZED PRODUCTS

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 … Read more

HANDLING OF PHARMACOPOEIAL CHANGES

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 … Read more

In-process checks during Dry powder injection manufacturing & packing (IPQA)

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 … Read more

PROCEDURE FOR AGREEMENT/QUALIFICATION OF EXTERNAL VALIDATION AGENCIES/SERVICES PROVIDERS/PARTIES

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 to cGMP systems covered as … Read more

INVESTIGATIONS SOP 

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 to Protocols, Master Batch Records … Read more

COMPRESSED AIR SYSTEM

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 requirements. The Quality refers to … Read more

MICROMETER SCREW GAUGE

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 object. It is also known … Read more

SOP ON ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT

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, process, product and environmental condition … Read more

QUALIFICATION OF CONTRACT TESTING LABORATORY

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 product, stability, water analysis, analytical … Read more

HANDLING OF ISOLATES

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 in the microbiology Laboratory. RESPONSIBILITY: … Read more

Premises, Equipment & Finishing of sterile products as per WHO TRS 961-Annex 6

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 complete observation of all operations … Read more

Operational qualification protocol cum report

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 typical operating range, as well … Read more