Quality Assurance - Pharma Egg

Jan292024 by KBS.No Comments

GMP Questionnaire for Excipients

Raw Material, General SOPS, General Topics, Microbiology, Product, Production, Quality Assurance, Quality Control, SOPs, Testing Methods

A Good Manufacturing Practice GMP Questionnaire for Excipients is a tool used to assess and qualify excipient suppliers to ensure compliance with regulatory standards and quality requirements. Part I: To be Completed by Supplier A) Contact Details Name: Address: Postal Code, City: Country: Telephone / fax / E-mail: Contact Person: Is your company the subsidiary of another company or corporation? Yes No If yes, please state name of parent company: Number of local employees: What services do you offer? (enclose a description, if applicable) Is your company certified according to MP (if yes, please enclose certificate) Yes No Part II: To be Completed by Manufacturer Only I confir...

Jan272024 by KBS.2 Comments

Laboratory Equipment Qualification Procedure SOP

Quality Assurance, Production, Quality Control, SOPs

Laboratory Equipment Qualification Procedure SOP outlines the steps and processes for qualifying laboratory equipment to ensure its reliability, accuracy, and compliance with regulatory requirements. Below is a general template for such a procedure. Please note that specific details may need to be tailored based on the type of equipment and regulatory requirements applicable to your laboratory. PURPOSE To describe the procedure for defining the responsibilities, planning, protocol writing, performing the qualification activity, and subsequent record generation. The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for the qualification of laboratory equipment to ensure accurate and reliable results and compliance with regulatory requirements. SCO...

Jan272024 by KBS.No Comments

SOP for Managing the Product Recall Process

Quality Assurance, General Topics, Production, SOPs

SOP for Managing the Product Recall Process is crucial for organizations to manage and execute an efficient and effective recall process when necessary. This SOP should provide clear guidelines on how to identify, initiate, and execute a product recall to minimize risks to consumers and comply with regulatory requirements. OBJECTIVE The purpose of this Work Instruction is to describe the procedure for the management of the recall, or potential recall, of sales products from the marketplace. Clearly state the purpose of the SOP, which is to establish a systematic process for managing product recalls to ensure the safety of consumers, comply with regulatory requirements, and protect the reputation of the organization. SCOPE This Work Instruction applies to all products manufactured and m...

Jan272024 by KBS.No Comments

SOP for Cleaning Validation and Solubility of Active Ingredients

Quality Assurance, Quality Control, SOPs

The SOP for Cleaning Validation and Solubility of Active Ingredients how to approval will be performed after Type A cleaning. After good Cleaning review just, the gear will took into Cleaning validation test. Swab tests and Rinse tests will be gathered to check the presence of dynamic buildup content and Microbiological bio trouble according to given examining plan. PURPOSE This procedure describes the strategy and basic requirement for validation of cleaning procedures before the manufacture of drug products which are necessary to prevent chemical and microbiological contamination Cleaning Validation Procedure. SCOPE It applies to all sections including Eye drops I.V solutions & SDF. All cleaning procedures which are applied to a specific process / product /system /equipment mus...

Jan252024 by KBS.No Comments

SOP for Manufacturing In process Control

Quality Assurance, General Topics, Production, SOPs

SOP for Manufacturing In process Control for Manufacturing In-Process Control is essential to ensure the quality and consistency of products during the manufacturing process. These procedures help monitor and control critical parameters at various stages of production. Purpose To describe procedures for manufacturing in process control. Clearly state the purpose of the SOP, which is to establish guidelines and procedures for the implementation of in-process controls to monitor and maintain the quality of products during manufacturing. Scope This SOP applies to all in process manufacturing control. Define the scope of the SOP, specifying the manufacturing processes and stages where in-process controls are applicable. Responsibilities It is the responsibility of QAIP and Assistant ...

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...