Tag Archives: Quebec

Hold Time Study Protocol

Hold Time Study Protocol 1. Objective \ Scope 1.1. Hold time study data shall give the assurance of the maximum allowable hold times for bulk and in-process drug products. Generally, one lot can be used for validating hold times if any inconsistency results were observed then another two lots can …

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CRITICAL AND MAJOR DEFICIENCIES

CRITICAL AND MAJOR DEFICIENCIES Compliance and enforcement measures are dependent upon a number of factors, including the significance of violations such as a “Critical” deficiency and a large number of “Major” deficiencies, the history of the site, potential risks to products, and assessment of the manufacturer’s proposed corrective actions. Where …

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GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies”

GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies” The GMP Deficiencies findings of a Good Manufacturing Practice (GMP) inspection can have a substantial impact on both your organization and, subsequently, public health. If the GMP Deficiencies found are classified as significant, they may necessitate cessation of manufacturing activities and/or product withdrawal from the …

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Air Handling Unit (AHU) and Working Principle

Air Handling Unit (AHU) and Working Principle An Air Handling Unit (AHU) is used to re-condition and circulate air as part of a heating, ventilating, and air-conditioning system. The basic function of the AHU is to take in outside air, re-condition it, and supply it as fresh air to a …

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Isolators In Pharma Industry

Isolators In Pharma Industry Isolators are clean air devices providing complete separation between an aseptic process (hazardous/non-hazardous), the technical personnel, and the surrounding work environment. Isolators are generally used in applications requiring a high degree of protection from external elements or contaminants, and they can serve as alternatives to sophisticated …

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Cleaning of Dispensing Area during Product Changeover

Cleaning of Dispensing Area during Product Changeover The area cleaning during Product Changeover: Start the cleaning operation of the ceiling and then to walls from top progressing to downwards. Clean the door and window glasses using a wet duster soaked with disinfectant solution. Clean the doors, door closure handles, and …

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Dispatch of Finished Goods

Dispatch of Finished Goods Procedure Arrange the pallets in the warehouse in an orderly manner. Place the finished goods, product wise on the pallets in the Finished Goods store. Arrange one product on one pallet. Place the batch of the product wise. After QC and QA release of the batch …

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Inspection, Sampling and Storage of Packing material

Inspection, Sampling, and Storage of Packing material Receipt and Inspection of Packing material Containers Upon receipt of packing material, the same shall be placed in the quarantine store attached to the Packing Material Store. In-charge of the Packing Material Store shall inform the QC Department for the inspection of containers …

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Handling of Spillage of Materials

Handling of Spillage of Materials Procedure Spillage of any material shall be handled immediately when observed and effectively as per the procedure mentioned below  : The personnel working in the concerned department shall immediately inform the Incharge of the concerned department about the spillage of material. The concerned department Incharge …

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Entry & Exit procedure in warehouse area

Entry & Exit procedure in the warehouse area Push the door of the primary changing room and enter the room. Remove your street footwear and unwanted articles like wristwatches, ornaments, etc., and keep them in respective lockers. Sanitize your feet by using a soak system having disinfectant. Cross the cross-over …

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Issuance of Packing Materials and transfer of Issued materials from Packing Material Store to Production

Issuance of Packing Materials and transfer of Issued materials from Packing Material Store to Production Procedure On the receipt of the requisition slip from the concerned production personnel for the manufacture of a product, the store In-charge shall ensure that the requisition slip bears the signatures of all the concerned …

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Cleaning of Raw Material Store, Packing Material Store and Finished Goods Store

Cleaning of Raw Material Store, Packing  Material Store and Finished Goods Store Procedure Collect all the waste material, dust settled over tables, floors, containers, furniture, fixtures & walls with the help of a vacuum cleaner. Clean the door, window glasses, door closures, handles, and all the hinges of the door …

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Dispensing of raw materials and transfer of dispensed materials from RM store to Production

Dispensing of raw materials and transfer of dispensed materials from RM store to Production Pre-start-up activity for dispensing & Issuance of Raw material: On the receipt of the requisition slip from the production department for the manufacture of a product, the store personnel shall ensure that the requisition slip bears …

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Stock Rotation of Raw Materials, Packing Materials and Finished Goods on the “First-in, First-out” basis

Stock Rotation of Raw Materials, Packing Materials, and Finished Goods on the “First-in, First-out” basis Objective To lay down a procedure to ensure proper stock rotation of Raw materials, Packing Materials, and Finished Goods so that the stock rotation of the materials may be on the “First-in, First-out” basis. Scope …

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Inventory Control of Materials and Components

Inventory Control of Materials and Components Procedure Raw Material Store, Packing Material Store and Finished Goods Store shall maintain proper records with respect to the Inventory Control of Materials and Components. Inventory Control regarding Raw Materials:-The following records shall be maintained by the Incharge of the Raw Material Store in …

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INSPECTIONS/AUDITS

INSPECTIONS/AUDITS 1. Manufacturing Process i. Drug Product (Dosage Form) In many cases, clinical production or trial runs of a new drug are produced in facilities other than the ones used for full-scale production. The facilities and controls used for the manufacture of the batch or batches are audited. For a …

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ELECTRONIC RECORDS

ELECTRONIC RECORDS  Scope (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. (b) This part applies to …

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Water Analysis as per IP/BP/USP

Water Analysis  as per IP/BP/USP Procedure for chemical testing and microbiological testing of Raw/Tap water, RO water, and purified water samples. Procedure for Water Analysis (Chemical & Microbiological) Carry out the determination under conditions designed to avoid extrinsic microbial contamination of the water sample for the analysis. The precautions taken …

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RESOURCES-THE QUALITY SYSTEMS MODEL

RESOURCES-THE QUALITY SYSTEMS MODEL Appropriate allocation of resources is key to creating a robust quality system and complying with the CGMP regulations. This section discusses the role of resources in developing, implementing, and managing a robust quality system that complies with CGMP regulations. 1. General Arrangements Under a robust quality …

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MANUFACTURING-THE QUALITY SYSTEMS MODEL

MANUFACTURING-THE QUALITY SYSTEMS MODEL Significant overlap exists between the elements of a quality system and the CGMP regulation requirements for manufacturing operations. It is important to emphasize again that FDA’s enforcement programs and inspectional coverage remain based on the CGMP regulations. When quality system elements in this section do not …

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