Handling and Storage of Empty Hard Gelatin Capsule Shells in Raw Material Store

Posted on By Pharmaceutical Guidanace

Handling and Storage of Empty Hard Gelatin Capsule Shells in Raw Material Store Objective To lay down a procedure for Handling and Storage of Empty Hard Gelatin Capsule Shells in Raw Material Store to prevent them from drying and embattlement or the absorption of moisture. Scope This Standard Operating Procedure is applicable in Raw Material…

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Warehouse

MICROBIOLOGICAL CONTROL FOR EXCIPIENTS, DRUG PRODUCT AND DRUG SUBSTANCE

Posted on By Pharmaceutical Guidanace

MICROBIOLOGICAL CONTROL FOR EXCIPIENTS, DRUG PRODUCT AND DRUG SUBSTANCE PURPOSE: To describe microbiological test controls to be applied for outsourced and in house drug substances, drug products and excipients. SCOPE: This SOP is applicable to drug substances, drug product, sterile drug product and excipients tested for microbiological quality. RESPONSIBILITY: Microbiologist shall be responsible for carrying…

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Microbiology

MANAGEMENT OF RAW DATA

Posted on By Pharmaceutical Guidanace

MANAGEMENT OF RAW DATA PURPOSE: To provide a procedure for recording, review, and storage of raw data at manufacturing sites. SCOPE: This SOP applies to all the raw data generated/collected during Warehousing, manufacturing/packaging operations, testing, environmental monitoring, operation and monitoring of equipment and utilities, calibrations, qualification and validation activities, cleaning, sterilization, and any other activity, which involve…

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Quality Assurance

STORAGE AND DISPOSAL OF EXHIBIT BATCHES OF DRUG PRODUCTS

Posted on By Pharmaceutical Guidanace

STORAGE AND DISPOSAL OF EXHIBIT BATCHES OF DRUG PRODUCTS PURPOSE: To describe a procedure for Storage and Disposal of Exhibit Batches of Drug Products. SCOPE: This standard operating procedure (SOP) is applicable to the exhibit batches of Drug Products manufactured and packed in the formulation manufacturing facilities. RESPONSIBILITY: Production: Transfers the exhibit batches to warehouse….

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Quality Assurance

Handling of Fallen off / Damaged Status labels

Posted on By Pharmaceutical Guidanace

Handling of Fallen off / Damaged Status labels Objective: To lay down a procedure for Handling of Fallen off / Damaged Status labels. Scope This Standard Operating Procedure is applicable for Handling Fallen-off / Damaged Status labels of Raw Material /Packing material at the formulation plant. Responsibility Concerned Department personnel shall be responsible for following…

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Warehouse

Operation and Cleaning of Refrigerator

Posted on By Pharmaceutical Guidanace

Operation and Cleaning of Refrigerator Objective: To lay down a procedure for the Operation and Cleaning of the Refrigerator in the Raw Material Store. Scope: This Standard Operating Procedure is applicable for the operation and cleaning of the Refrigerator in the Raw Material Store at the formulation plant. Responsibility Raw material Store personnel shall be…

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Warehouse

Cleaning of SS Trolleys, Pallets and Racks

Posted on By Pharmaceutical Guidanace

Cleaning of  SS Trolleys, Pallets and Racks Objective: To lay down a procedure for cleaning SS Trolleys, Pallets, and Racks Scope: This SOP is applicable for cleaning SS Trolleys, Pallets, and Racks in the Raw Material Store/packing material/finished goods at the formulation plant. Responsibility Store personnel shall be responsible for following the procedure mentioned in…

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Warehouse

SYSTEM MAINTENANCE PROCEDURE FOR STABILITY CHAMBER

Posted on By Pharmaceutical Guidanace

SYSTEM MAINTENANCE PROCEDURE FOR STABILITY CHAMBER GENERAL MAINTENANCE ONLY TRAINED AND SKILLED PERSONS SHOULD MAINTAIN THE MACHINE. Follow work permit procedure before any maintenance work. Thermolab will not be responsible if the same is ignored. Check whether the stability chamber is clean from inside and outside after use. Check the humidity tank, kettle heater and…

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Quality Control

House keeping

Posted on By Pharmaceutical Guidanace

Housekeeping OBJECTIVE:  To lay down a standard operating procedure for Housekeeping in the factory. SCOPE: This SOP is applicable for Housekeeping. RESPONSIBILITY: Officer/ Executive – HR ACCOUNTABILITY: Manager/ Head- QA / All Concerned HOD PROCEDURE: CLEANING TOOLS: Mops, Wiper, Glass wiper, Glass cleaner and Vacuum Cleaner and plastic broom shall be used for cleaning. PREPARATION OF DISINFECTANTS AND…

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Uncategorized

PROCEDURE FOR HANDLING OF EXTERNAL AUDITS

Posted on By Pharmaceutical Guidanace

PROCEDURE FOR HANDLING OF EXTERNAL AUDITS OBJECTIVE: The purpose of this SOP is to lay down the procedure for handling of external inspections / audits by the agencies and customers for various products. SCOPE: This procedure is applicable for handling of external inspections / audits. RESPONSIBILITY: Site Head: To welcome auditors at opening meeting. To…

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Quality Assurance

HANDLING OF BIOHAZARDOUS MATERIAL IN MICROBIOLOGY LAB

Posted on By Pharmaceutical Guidanace

HANDLING OF BIOHAZARDOUS MATERIAL IN MICROBIOLOGY LAB PURPOSE: To outline the procedure for Handling Biohazardous Material in the Microbiology Lab. SCOPE:  This procedure is applicable for Handling Biohazardous Material in the Microbiology Lab. REFERENCE(S) & ATTACHMENTS REFERENCES In-House ISO 45001:2018 CROSS-REFERENCE DOCUMENTS Preparation, Review, Approval, Issuance & Retrieval of Standard Operating Procedures (SOPs) Change Control…

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Microbiology

HANDLING OF AUDIT TRAIL

Posted on By Pharmaguidanaces Channel

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…

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Quality Control

COMPUTERIZED SYSTEM LIFE CYCLE

Posted on By Pharmaguidanaces Channel

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…

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Quality Control

AUDIT OBSERVATIONS

Posted on By Pharmaguidanaces Channel

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…

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Quality Assurance

VERIFICATION AND TESTING OF FINISHED GOODS

Posted on By Pharmaguidanaces Channel

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…

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Quality Assurance

SHELF LIFE EXTENSION OF EXISTING COMMERCIALIZED PRODUCTS

Posted on By Pharmaguidanaces Channel

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…

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Quality Control

HANDLING OF PHARMACOPOEIAL CHANGES

Posted on By Pharmaguidanaces Channel

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…

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Quality Control

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

Posted on By Pharmaguidanaces Channel

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…

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Quality Assurance

Liquid Bourne Particle counter (LBPC)

Posted on By Pharmaceutical Guidanace

Liquid Bourne Particle counter (LBPC) Objective: To lay down the procedure for Cleaning, Operation, Maintenance, and Analysis of samples using LBP counter. Scope: This SOP is applicable for the Operation, Cleaning, Maintenance and Analysis of LBPC samples in the manufacturing department. Responsibility: Microbiologist / IPQA personnel are responsible for follow the procedure. Accountability: Head – Quality Assurance…

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Quality Assurance