Shipping Validation Objective The objective of this study is to establish a procedure to record temperature data to ensure that transportation conditions have not adversely affected a product until it reaches the Central Warehouse when transported as per regular Shipment practice. Scope The protocol shall be applicable at the formulation Plant. The Shipping (Transportation) validation…
COATING PANS CONTENTS: COATING PROCESSES TYPES OF COATING PANS CONVENTIONAL COATING PANS PERFORATED COATING PANS VALIDATION OF COATING PANS IQ OQ PQ REFERENCES Main coating processes Film coating Sugar coating Sugar coating Traditionally sugar coatings formed the bulk of coated tablets but today film coatings are the more modern technology in tablet coating. Description of…
AUTOCLAVE – MAINTENANCE AND VALIDATION. INTRODUCTION An autoclave is a device to sterilize equipment and supplies by subjecting them to high pressure steam at 121° C or more. It was invented by Charles Chamberland in 1879,although a precursor known as the steam digester was created by Denis Papin in 1679. The term autoclave is also…
WEIGHTS AND BALANCES AND ANALYTICAL BALANCE The requirements for weights into conformity with American National Standard ANSI/ASTM E617, “Laboratory Weights and Precision Mass Standards.” Pharmacopeial tests and assays require balances that vary in capacity, sensitivity, and reproducibility. Unless otherwise specified, when substances are to be “accurately weighed” for Assay, the weighing is to be performed…
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Pharma Definitions 1. Aseptic processing A process performed maintaining the sterility of a product that is assembled from components, each of which has been sterilized by steam, dry heat, ionizing radiation, gas or sterile filtration. This is achieved by using conditions and facilities designed to prevent microbiological contaminants. 2. Bioburden The total number of micro-organisms…
Purpose : Operation and calibration procedures of melting point apparatus SCOPE : Is applicable to the operation and calibration procedures of melting point apparatus RESPONSIBILITY : Quality Control Analyst shall be responsible to follow the procedure mentioned in this SOP ACCOUNTABILITY: QC Head and QA Head shall be accountable for compliance of this SOP ATTACHMENTS…
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Purpose : To lay down a procedure for personnel management system. SCOPE : This SOP is applicable to the Human Resource Department. RESPONSIBILITY : Head Human Resource and Management. ACCOUNTABILITY : Quality Assurance Head ATTACHMENTS : Not applicable PROCEDURE: Personnel department will lay out the personnel management system which includes identification of staff position, the responsibilities…
PURPOSE: procedure for cleaning of microbiological Laboratory. SCOPE: To maintain high standards of cleaning in microbiology lab. RESPONSIBILITY : Done by: Microbiologist. ACCOUNTABILITY : Quality Control Head ATTACHMENT :ANNEXURE-I RECORD OF HOUSE KEEPING IN MICROBIOLOGY LABORATORY PROCEDURE: Cleaning shall be done daily Floors shall be mopped daily with water containing disinfectants. Possible use of any disinfecting…
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Dispensing of raw material OBJECTIVE Procedure of dispensing raw materials. SCOPE This SOP is applicable for dispensing of all raw materials. RESPONSIBILITY Warehouse, production and QA staff shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY Warehouse In-Charge and QA Head shall be accountable for compliance of the procedure mentioned in this…
Operation and cleaning of vacuum cleaner OBJECTIVE Procedure for operation and cleaning of vacuum cleaner. SCOPE This procedure is applicable in the Warehouse RESPONSIBILITY Warehouse personnel shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY Warehouse In-Charge and QA Head shall be accountable for compliance of the procedure mentioned in this SOP….
Temperature and humidity monitoring OBJECTIVE The procedure of temperature and humidity monitoring in the storage and dispensing area. SCOPE This SOP is applicable for monitoring temperature and humidity in the storage area/ dispensing area. RESPONSIBILITY Warehouse personnel shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY Warehouse In-Charge and QA Head shall…
Storage of finished goods OBJECTIVE The procedure of storing Finished Goods. PROCEDURE The packs of the product received from production are to be stored in the quarantine area. After the Finished Product is analyzed by QC, the QC department sends a copy of the COQ to the warehouse. The details concerning the products are recorded…
Storage conditions of material OBJECTIVE Procedure for storage condition of the material. SCOPE This SOP is applicable for the storage condition of materials. RESPONSIBILITY Warehouse, Quality Control, Quality Assurance, and Production personnel shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY: Warehouse In-Charge and QA Head shall be accountable for the compliance…
Receipt of returnable excess OBJECTIVE Receiving returnable excess materials from the production department. SCOPE This SOP is applicable for receiving the returnable excess material. RESPONSIBILITY Warehouse personnel, Production personnel, and IPQA shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY The warehouse in–charge, Production Head, and QA Head shall be accountable for…
Receipt of finished goods OBJECTIVE To lay down a procedure for receipt of finished goods. SCOPE This SOP is applicable for receiving of finished goods in the finished goods stores. RESPONSIBILITY Warehouse Officer and QA Officer shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY Warehouse In-Charge and QA Head shall be…
Receipt and storage of Raw and Packing Materials OBJECTIVE To lay down a procedure for receiving and storing raw material and packing material. SCOPE This SOP is applicable to all raw materials and packing materials. RESPONSIBILITY Warehouse Personnel shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY Warehouse In-Charge and Quality Assurance…
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Qualification of HEPA – filters of sampling and dispensing booths OBJECTIVE To lay down a procedure of qualification or re-qualification of HEPA filter of sampling and dispensing booths. SCOPE This SOP is applicable for the Qualification of the HEPA filter of the sampling & dispensing booths to check the integrity of the filter, and define…
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Pressure differential monitoring OBJECTIVE: To lay down a procedure for monitoring differential pressure across the filter of the Dispensing Booth. SCOPE: This SOP is applicable for monitoring differential pressure in front of and after the filter. RESPONSIBILITY Warehouse personnel shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY Warehouse Head and QA…
Movement of dispensed materials OBJECTIVE To lay down a procedure of movement of dispensed raw and packing material to the production area. SCOPE This SOP is applicable for transferring dispensed raw materials and packing materials to the production area. RESPONSIBILITY Stores Officer, QA Officer, Production Supervisor, and Packing Supervisor shall be responsible to follow the…
