SOP ON SWAB /RINSE SAMPLING PURPOSE: To lay down a procedure for sampling a swab or rinse sample from different equipment or areas. SCOPE: This SOP applies to sampling rinse or swabs from different equipment/parts/areas at various stages of product processing. REFERENCE: In-House CROSS-REFERENCE DOCUMENTS Quality Risk Management SOP on Investigation ATTACHMENTS: S.No. Attachment No. Attachment…
PROCEDURE FOR ALLOCATION OF ROOM NUMBERS PURPOSE: To define the procedure for allocation of Room Numbers for various rooms in manufacturing site. SCOPE: This SOP is applicable for allocation of Room Numbers for various rooms in the manufacturing site. REFERENCE(S): In house CROSS-REFERENCE DOCUMENTS: Preparation, Review, Approval, Issuance & Retrieval of SOPs Good Document Practice ATTACHMENTS S.No….
SOP ON ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT PURPOSE: To lay down a procedure for the establishment of an Alert Limit and Action Limit. SCOPE: This SOP applies to critical stages of the system, analytical test / Microbial test, online results regarding water system, process, product and environmental condition of clean room like Temperature, Relative…
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PRODUCT PROCESS QUALIFICATION (PPQ) PURPOSE: The purpose of this procedure is to provide a high degree of assurance of meeting all the predefined attributes and the process is capable of consistently delivering quality products. SCOPE: This SOP is applicable for Process Qualification activities of drug products manufactured. REFERENCE(S) ISPE, Volume 5, Commission & Qualification. Guidance for Industry:…
SPECIMEN SIGNATURE OF EMPLOYEE PURPOSE: To lay down a procedure for maintaining the specimen signatures of employees. SCOPE: This SOP applies to all employee(s) responsible for recording & approval of cGMP documents /data related to manufacture analysis and distribution of product /material. REFERENCE(S): In house CROSS-REFERENCE DOCUMENTS: Induction & behavioral training Data integrity & Data Reliability Job Responsibility…
SOP ON JOB RESPONSIBILITY PURPOSE: To lay down the procedure for defining the job responsibilities of all employees working in the company. SCOPE: This SOP applies to all the employees, working in all departments/Sections. OTHER RESOURCES: BURN CURE CREAM (Acriflavine & Thymol Cream) ATTACHMENT(S) S.No. Attachment No. Attachment Title 1. Attachment-I Job Responsibilities 2. Attachment-II Delegation…
PROCEDURE FOR IN-HOUSE & OUTSIDE PARTY CALIBRATION PURPOSE: To lay down a procedure for calibration of all the testing and measuring instruments or devices used to measure critical processes that can have an impact on the quality of the product. SCOPE: This procedure covers the calibration of measuring instruments like pressure gauges’ temperature gauges, vacuum gauges, temperature…
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SOP ON CLEANING, OPERATION, AND CALIBRATION OF LEAK TEST APPARATUS PURPOSE: To define a Cleaning, Operation, and calibration procedure for Leak test apparatus. SCOPE: This SOP applies to the Cleaning, Operation, and calibration of the Leak test apparatus. Instrument Name Instrument ID Make / Model Location Leak test apparatus AA/QAD/LTA-01 Labo IPQA (Liquid/Dry powder) Leak test apparatus…
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PROCEDURE FOR QUALIFICATION/ REQUALIFICATION OF SYSTEM/ EQUIPMENT/ UTILITY/ INSTRUMENTS PURPOSE: To describe the procedure for equipment/facility qualification: prepare qualification protocols, to initiate, conduct, and document equipment/facility qualification studies. SCOPE: This SOP shall apply to all new and upgraded process-related equipment/facility. REFERENCE(S): ISPE, Volume 5, Commission & Qualification. ATTACHMENTS S.No Attachment No. Attachment Title 1 Attachment-I Template for Design…
REPROCESSING AND REWORKING SEMI-FINISHED AND FINISHED PRODUCTS PURPOSE: To lay down a procedure for reprocessing and reworking of semi-finished and finished products. SCOPE: This SOP applies to the process of out-of-specification semi-finished and finished Products, recalled or market returned and recoverable residues. REFERENCE(S): Drug and Cosmetics Act 1945 WHO-TRS no. 986; 2014. CROSS-REFERENCE DOCUMENTS: Document(s) and…
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