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…
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…
Inspection of incoming foil OBJECTIVE: To lay down a procedure for the incoming inspection of foil rolls. PROCEDURE: After the security staff checks and allows the vehicle to enter the plant area, check the documents for foil rolls received – purchase orders/ invoices. Check the vendor as per the vendor list. If the material comes…
Dispensing of additional materials OBJECTIVE : To lay down a procedure for dispensing additional material. PROCEDURE Production personnel must send a filled Additional Material Requirement Note (AMRN) for the necessary additional materials. The following details have to be entered in the AMRN. Date Product name Batch number Material name Material code, Document number Unit of measurement…
Dispensing of packing material OBJECTIVE: To lay down a procedure for dispensing packing material. PROCEDURE Get the order for a certain packing material at least one day in advance. The FIFO method has to be used while dispensing packing material. The packing material should be taken by the workers of the store only after checking the…
Dispatch of finished goods OBJECTIVE: To lay down the procedure for dispatching finished goods from the warehouse. ATTACHMENTS :Register of Finished product PROCEDURE When you ensure that the batch is approved by QA and released by Authorized Person, start dispatching as per the order, received from the shipping department. Prepare the required quantity of corrugated…
Cleaning Of Sampling Booth OBJECTIVE To lay down a cleaning procedure for the Sampling booth. PROCEDURE DIFFERENT MATERIAL CHANGE OVER Remove all the containers and the materials of the product. Remove the area and the equipment status label. Transfer all the sampling aids to the QC department washing area. Remove the pre-filters and clean the…
