PROCEDURE FOR AGREEMENT/QUALIFICATION OF EXTERNAL VALIDATION AGENCIES/SERVICES PROVIDERS/PARTIES

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VALIDATION: PROCEDURE FOR AGREEMENT/QUALIFICATION OF EXTERNAL VALIDATION AGENCIES/SERVICES PROVIDERS/PARTIES The purpose of this SOP is to lay down procedure for selection Qualification and approval of Service Providers for Outsourced activities of manufacturing sites  This procedure shall be applicable for approving, controlling and reviewing of Service Providers supporting outsourced activities relevant to cGMP systems covered as…

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Quality Assurance

INVESTIGATIONS SOP 

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INVESTIGATIONS SOP  This Standard Operating Procedure (SOP) defines the requirements for reporting, documenting, investigating, evaluating, managing, resolving and approving closure of investigations from cGxP, approved specifications and/or procedures. This standard applies to Investigations related to quality related events that occur from cGxP, approved specifications, and/or procedures including but not limited to Protocols, Master Batch Records…

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Quality Assurance

SOP ON ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT

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SOP ON ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT To lay down a procedure for establishment of Alert Limit and Action Limit. ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT OF SCOPE This SOP is applicable to critical stages of system, analytical test / Microbial test, on-line result regarding water system, process, product and environmental condition…

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Microbiology

Premises, Equipment & Finishing of sterile products as per WHO TRS 961-Annex 6

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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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Small Volume Parenteral

Operational qualification protocol cum report

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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…

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Uncategorized

Design of HVAC systems and components as per TRS 1010

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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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Engineering

GOOD MICROBIOLOGY LABORATORY PRACTICES

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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…

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Microbiology

PERSONNEL TRAINING, QUALIFICATION,MONITORING AS PER USFDA GUIDELINE

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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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Small Volume Parenteral

Critical Area – Class 100 (ISO 5) AS PER USFDA GUIDELINE

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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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Small Volume Parenteral

VALIDATION OF ASEPTIC PROCESSING AS PER USFDA GUIDELINE

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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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Small Volume Parenteral

High-Efficiency Particulate Air (HEPA) As Per USFDA GUIDELINE

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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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Small Volume Parenteral

Air Filtration by Membrane AS PER USFDA GUIDELINE

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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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Small Volume Parenteral

Alcoa++

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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…

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Quality Assurance

CIP -Cleaning In Place 

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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,…

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Production