GENERAL PLANNING & WORKS INSTRUCTION IN PRODUCTION
GENERAL PLANNING & WORKS INSTRUCTION IN PRODUCTION STATUS LABELLING PROCEDURE FOR INPROCESS MATERIAL, EQUIPMENT AND AREA
DISPOSAL OF WASTE MATERIALS OF MANUFACTURING AREAS
DISPOSAL OF WASTE MATERIALS OF MANUFACTURING AREAS GENERAL PLANNING & WORKS INSTRUCTION IN PRODUCTION
STATUS LABELLING PROCEDURE FOR INPROCESS MATERIAL, EQUIPMENT AND AREA
STATUS LABELLING PROCEDURE FOR IN-PROCESS MATERIAL, EQUIPMENT AND AREA DISPOSAL OF WASTE MATERIALS OF MANUFACTURING AREAS
Premises, Equipment & Finishing of sterile products as per WHO TRS 961-Annex 6
Premises, Equipment & Finishing of sterile products as per WHO TRS 961-Annex 6 It is highly recommended that all premises are designed in a way that minimizes the unnecessary entry of supervisory or control personnel. Specifically, Grade A and B areas should be constructed in a manner that allows for complete observation of all operations…
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Operational qualification protocol cum report
Operational qualification Documented verification that the system or subsystem operates as intended overall anticipated operating ranges as per WHO TRS 1019-annex3. The OQ should furnish documented proof that utilities, systems, or equipment are functioning in compliance with operational specifications. The tests should be formulated to exhibit satisfactory performance within the typical operating range, as well…
STORAGE OF BULK AND SEMI-FINISH TABLETS
STORAGE OF BULK AND SEMI-FINISH TABLETS
Design of HVAC systems and components as per TRS 1010
Design of HVAC systems and components Proper design and management of HVAC systems is crucial throughout their entire life cycle. It is important to maintain documentation, such as schematic drawings, to accurately reflect the current state of the system. To ensure the safety and effectiveness of HVAC systems, risk management principles should be applied. This…
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GOOD MICROBIOLOGY LABORATORY PRACTICES
GOOD MICROBIOLOGY LABORATORY PRACTICES To provide general guidance on Good laboratory practices in microbiology laboratory consisting of activities that depend on several principles, aseptic techniques, control of media, control of test strains, and control of equipment’s, personnel hygiene, health and garments. SCOPE GOOD MICROBIOLOGY LABORATORY PRACTICES: This SOP is applicable for Microbiology lab. RESPONSIBILITY: Concerned…
PERSONNEL TRAINING, QUALIFICATION,MONITORING AS PER USFDA GUIDELINE
PERSONNEL TRAINING, QUALIFICATION, MONITORING AS PER USFDA GUIDELINE Personnel Training A well-designed, maintained, and operated aseptic process minimizes personnel intervention. As operator activities increase in an aseptic processing operation, the risk to finished product sterility also increases. To ensure the maintenance of product sterility, operators involved in aseptic activities must use aseptic techniques at all…
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Critical Area – Class 100 (ISO 5) AS PER USFDA GUIDELINE
Critical Area – Class 100 (ISO 5) AS PER USFDA GUIDELINE A critical area is one in which the sterilized drug product, containers, and closures are exposed to environmental conditions that must be designed to maintain product sterility (§ 211.42(c)(10)). Activities conducted in such areas include manipulations (e.g., aseptic connections, sterile ingredient additions) of sterile…
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VALIDATION OF ASEPTIC PROCESSING AS PER USFDA GUIDELINE
VALIDATION OF ASEPTIC PROCESSING AS PER USFDA GUIDELINE Process Simulations To ensure the sterility of products purporting to be sterile, sterilization, aseptic filling, and closing operations must be adequately validated (§ 211.113). The goal of even the most effective sterilization processes can fail to achieve their objective if the sterilized components of a product, such…
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High-Efficiency Particulate Air (HEPA) As Per USFDA GUIDELINE
Air Filtration – High-Efficiency Particulate Air (HEPA) As Per USFDA GUIDELINE HEPA filter integrity should be maintained to ensure aseptic conditions. Leak testing should be performed at installation to detect integrity breaches around the sealing gaskets, through the frames, or at various points on the filter media. Thereafter, leak tests should be performed at suitable…
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Air Filtration by Membrane AS PER USFDA GUIDELINE
Air Filtration by Membrane AS PER USFDA GUIDELINE Air Filtration by Membrane – A compressed gas should pass for purity test to ensure it is free from oil and meets the required standards for microbiological and particle quality after filter. The quality of the compressed gas should be at least equal to the air quality…
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Alcoa++
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…
CIP -Cleaning In Place
CIP -Cleaning In Place CIP, also known as Cleaning In Place, is a methodical and automated technique used to clean the inner surfaces of manufacturing equipment, including tanks, pipes, and vessels, without the need for disassembly. This approach is extensively utilized in the pharmaceutical sector to remove any remnants of the previous product, cleaning agents,…
RECEIVING OF RAW MATERIALS FROM THE DISPENSING AREA TO THE PRODUCTION DAY STORE AREA
RECEIVING OF RAW MATERIALS FROM THE DISPENSING AREA TO THE PRODUCTION DAY STORE AREA
GOOD LABORATORY PRACTICE
GOOD LABORATORY PRACTICE Good Laboratory Practices (GLP) is a quality system concerned with organizational process and conditions under which non-clinical health and environment safety studies are planned, performed, monitored recorded, archived, and reported.
CLEANING OF CONTAINERS USED TO HOLD PROCESS MATERIAL
CLEANING OF CONTAINERS USED TO HOLD PROCESS MATERIAL
Introduction of New Product in Facility
Introduction of New Product in Facility The implementation of a novel product in a pharmaceutical industries necessitates a Carefully planned & organized sequence of actions to guarantee a seamless and adheres to regulations and guidelines. Below is an exhaustive compilation of activities that should be taken into account: New Product Project Planning: Create a project plan…
Emulsion & Role of Emulsifying Agents
Emulsion & Role of Emulsifying Agents Emulsion refers to a colloidal dispersion where two liquids that do not mix are blended uniformly. It comprises small droplets of one liquid dispersed in another liquid. The stability of emulsions is of utmost importance in various industries such as food, pharmaceuticals, and cosmetics. Emulsifying agents are commonly employed…