Alcoa++ In a world where data plays a crucial role in decision-making and technological advancements shape various industries, the significance of data integrity cannot be emphasized enough. Alcoa, a company renowned for its commitment to excellence, extends the principles of Alcoa Plus Plus beyond aluminum production to prioritize data integrity as a fundamental aspect of…
Good Manufacturing Practices (GMPs) CGMPs provide systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Good Manufacturing Practices (GMPs) are the basic manufacturing and environmental conditions required to produce pharmaceutical products. They ensure that ingredients, products, and packaging materials are handled safely and that pharmaceutical products are processed in a suitable…
Liquid pharmaceutical Preparations A solution is a homogenous one-phase system consisting of two or more components. →solvent + solute • The solvent is that phase in which the dispersion occurs and the solute is that component that is dispersed as small molecules or ions in the solvent. • Liquid preparations: the formulation prepared by dispersing…
PARENTERAL PREPARATIONS Parenteral preparations are sterile preparations intended for administration by injection, infusion, or implantation into the human or animal body. Parenteral preparations may require the use of excipients, for example, to make the preparation isotonic with respect to blood, to adjust the pH, to increase solubility, to prevent deterioration of the active substances, or…
Most common types of pharmaceutical contamination Contamination can lead to objectionable results in the Pharma industry. It can conciliate the safety of patients, staff, and the environment – as well as affect the market. High standards of hygiene are important to maintain, only preventing the bio-burden levels by means of effective cleaning is not sufficient:…
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HVAC SYSTEM AND TEST FOR HVAC QUALIFICATION What is HVAC? HVAC controls Temperature, Humidity, and Air quality inside a building. HVAC technology aims to provide thermal comfort and acceptable indoor air quality. HVAC system design is a sub-discipline of mechanical engineering, based on the principles of thermodynamics, fluid mechanics, and heat transfer. The HVAC system is…
PROCEDURE FOR ROUNDING OFF NUMERICAL VALUES AND REPORTING SYSTEM
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 be used for this study….
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 appropriate, this may include an…
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 market. In the advent of…
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PROTOCOL for Air Handling Unit (AHU)/HVAC REPORT for Air Handling Unit (AHU)/HVAC
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 cleanrooms. Isolators typically feature built-in…
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 all the hinges of the…
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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 as per the procedure defined…
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 and taking of samples for…
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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 shall inform QA about the…
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 bench (COB) as displayed in…
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 persons. The packing Material 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 using a clean dry duster…
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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 the signature of all the…
