Quality Assurance - Pharma Egg

Jan252024 by KBS.No Comments

Standard operating procedure for Equipment Qualification

Quality Assurance, General Topics, Production, Quality Control, SOPs

Standard operating procedure for Equipment Qualification is a critical process in various industries, including pharmaceuticals, biotechnology, healthcare, and manufacturing. It ensures that equipment meets specified requirements and is suitable for its intended purpose. Standard Operating Procedures (SOPs) for equipment qualification help maintain consistency, reliability, and compliance with regulatory standards. Objective: Objective of this SOP is to address the guidelines for the execution of the Equipment Qualification i.e. (Installation Qualification (IQ)), (Operational Qualification (OQ)) and (Performance Qualification (PQ)). Clearly state the purpose of the SOP, which is to define the systematic process for qualifying equipment to ensure its reliability, accuracy, and compliance ...

Jan252024 by KBS.No Comments

Determining Shelf Life And Stability Testing Programme

Quality Assurance, General Topics, Product, Production, Quality Control, SOPs

Standard Operating Procedure for Determining Shelf Life And Stability Testing Programme Determining Shelf Life And Stability Testing Programme is the stability testing programmed for all pharmaceutical products manufactured at Company facility confirm the stability of the products and compatibility. PURPOSE To describe the stability testing programmed for all pharmaceutical products manufactured at Company facility. To confirm the stability of the products and compatibility with its container, while stored in accordance with labeling conditions and time, and with respect to product degradation. Pharmaceutical products will be tested at designated intervals for certain physical, chemical and microbiological properties. To collect scientific evidence based on test results to d...

Jan62024 by KBS.No Comments

SOP for Conduction of Validation Study

Quality Assurance, General SOPS, SOPs

A Standard Operating Procedure SOP for Conduction of Validation Study is critical in the pharmaceutical industry to ensure that processes, equipment, and systems are validated according to regulatory requirements. This procedure SOP for Conduction of Validation Study is to establish a systematic and documented approach for planning, conducting, and documenting validation studies to ensure that processes, equipment, and systems meet predetermined acceptance criteria and comply with regulatory requirements. Objective: To establish and maintain product integrity, performance and reliability, and to ensure that systems, procedures and equipments are clearly defined, functioning correctly, and are shown to be equipped to achieve the desired results. SOP for Conduction of Validation Stud...

Jan62024 by KBS.No Comments

SOP for Handling of Product Complaints

Quality Assurance, General SOPS, SOPs

A Standard Operating Procedure SOP for Handling of Product Complaints is crucial in the pharmaceutical industry to ensure timely and effective resolution of customer complaints and to meet regulatory requirements. Purpose To describe procedure for handling, investigation and reporting of Product Complaints SOP for Handling of Product Complaints Scope The scope of this document pertains to all type of internal and external complaints of finished products manufactured and marketed by Pacific Pharmaceuticals Ltd Responsibilities It is the responsibility of distribution manager to forward the complaint received from distributor, retailer or customer to QA . In case of internal complaint, Head of Department is responsible to forward the complaint to QA. It is responsibility of Q...

Jan62024 by KBS.No Comments

SOP for Qualification of Service Provider

Quality Assurance, General SOPS, Production, SOPs

A Standard Operating Procedure SOP for Qualification of Service Provider is essential in the pharmaceutical industry to ensure that external entities providing services meet the necessary quality and regulatory requirements. This SOP for Qualification of Service Provider is to establish a systematic and documented approach for the qualification, selection, and ongoing assessment of external service providers to ensure that they meet the quality and regulatory requirements of the pharmaceutical organization. Purpose To describe procedure for qualification of service provider. SOP for Qualification of Service Provider Scope The scope of this document pertains to qualification of service provider of Pharmaceuticals Ltd Responsibilities It is the responsibility of Procurement de...

Jan62024 by KBS.No Comments

SOP for Management of Documents

Quality Assurance, General SOPS, SOPs

A Standard Operating Procedure SOP for Management of Documents is crucial in pharmaceutical manufacturing to ensure the control, organization, and traceability of documents. The following is a general outline for creating an SOP for the Management of Documents Purpose To manage all the regulated / GMP documents SOP for Management of Documents Scope The scope of this document pertains to but not limited to all SOPs, forms, records, templates, protocols, reports and related attached documents prepared at Pharmaceuticals Ltd Responsibilities It is the responsibility of QA to prepare, manage and properly implement this SOP. QA ensures that this SOP is followed in its entirety. It is the responsibility of QA Manager or Designee to review this SOP. It is the responsibility o...

Jan62024 by KBS.No Comments

SOP for cGMP Internal Audit / Self Inspection

Quality Assurance, General SOPS, Production, Quality Control, SOPs

A Standard Operating Procedure SOP for cGMP Internal Audit / Self Inspection in the pharmaceutical industry is vital for ensuring compliance with Good Manufacturing Practice (cGMP) guidelines and maintaining a high level of quality and safety in the manufacturing process. Below is a general outline for creating an SOP for cGMP Internal Audit or Self-Inspection Purpose To describe procedure for planning, executing, reporting and follow up of cGMP internal audit as well as Self Inspection SOP for cGMP Internal Audit / Self Inspection Scope The scope of this document pertains to all regulated departments including, Production, Quality Control, Quality Assurance, Procurement, Engineering, Warehouses and IT department of Pacific Pharmaceuticals Ltd Responsibilities QA Head is respon...

Jan62024 by KBS.No Comments

Out of Specifications (OOS) Handling Procedure

Quality Assurance, General SOPS, SOPs

A Standard Operating Procedure (SOP) for Out of Specifications (OOS) Handling Procedure results in the pharmaceutical industry is crucial for managing deviations from established specifications during the testing or manufacturing of pharmaceutical products. Below is a general outline for creating an SOP for handling Out-of-Specification results. Purpose To describe procedure for reporting, investigating and responding out of specification (OOS) analytical results Out of Specifications (OOS) Handling Procedure Scope The scope of this document pertains to the OOS results in QC for Raw materials / Packaging materials, In Process and Finished Products for releasing at Pharmaceuticals Ltd Responsibilities It is the responsibility of all laboratory personnel working in QC to ensure tha...

Jan62024 by KBS.No Comments

SOP for Change Control in Pharmaceuticals

Quality Assurance, General SOPS, General Topics, SOPs

A Standard Operating Procedure SOP for Change Control in Pharmaceuticals industry is a critical document that outlines the systematic approach for managing and documenting changes to processes, systems, equipment, facilities, or any other aspect that may impact product quality, safety, or efficacy. The following is a general outline for creating an SOP for Change Control in Pharmaceuticals: Purpose To describe procedure for controlling and documenting changes Scope SOP for Change Control in Pharmaceuticals The scope of this document pertains to all major and minor changes related to all approved documents, computerized system, utilities, facilities, equipment, instruments and vendors at www.eggpharma.com Responsibilities It is the responsibility of QA to prepare, manage and p...

Jan32024 by KBS.No Comments

SOP for Environmental Risk Assessment Procedure

Quality Assurance, General SOPS, SOPs

This SOP is to establish a systematic and standardized process for conducting environmental risk assessments to identify, evaluate, and mitigate potential SOP for Environmental Risk Assessment Procedure associated with activities, processes, or products within the organization. 1 PURPOSE of SOP for Environmental Risk Assessment Procedure The purpose of this procedure is to provide a system and instructions to assess and control occupational hazards/aspects of activities, products, and services of www.pharmaegg.com group of companies. This includes to. Evaluate the associated risks and environmental impacts using the risk assessment matrix and prioritize them. Reduce the risks by controlling hazards and environmental aspects using appropriate engineering and administrative control...