SOPs

Standard Operating Procedures (SOPs) provides end-users with clear instructions on how to work and develop enough to ensure that all end-users can perform their tasks in a consistent and consistent manner. Many processes can be difficult, and it is important to have a balance between too few and too many points. If there are too few points, the end-user will follow their path. On the other hand, too much information and too much detail increase the risk that the end-user will struggle to understand and perform everyday steps, resulting in errors and omissions.

Sops are of different types like Quality Control SOPs, General SOPs, Production SOps, R&D, Regulatory and Validation SOPs etc

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...

Jan282024 by KBS.No Comments

SOP for Supplier Qualification of Excipients

Microbiology, Quality Control, SOPs

A Standard Operating Procedure SOP for Supplier Qualification of Excipients is essential to ensure the quality, safety, and regulatory compliance of the materials used in pharmaceutical and other industries. Excipients are critical components of drug formulations, and it is crucial to establish a systematic process for qualifying and approving suppliers. Purpose To describe procedure for selection, qualification and approval of Excipient’s supplier including domestic and foreign manufacturer To establish a standardized process for the qualification of suppliers providing excipients. To ensure the quality, safety, and regulatory compliance of excipients used Pharmaceuticals products. Scope The scope of this document pertains to suppliers of all excipients used in Pharmac...

Jan282024 by KBS.No Comments

Sterility Test of Large Volume Products by Filtration Method

Microbiology, General Topics, Quality Control, SOPs

A Sterility Test is a critical procedure in pharmaceutical and biopharmaceutical industries to ensure that large volume parenteral products are free from viable microorganisms. The filtration method is commonly employed for the sterility testing of large volume products. Below is a general outline for an SOP for Sterility Test of Large Volume Products by Filtration Method PURPOSE To assure the sterility of aseptically, terminal sterilized filled large volume products. To establish a standardized procedure for conducting Sterility Tests on large volume parenteral products. To ensure the absence of viable microorganisms in large volume products intended for parenteral administration. SCOPE This SOP is applicable to aseptically, terminal sterilized filled large volume prod...

Jan282024 by KBS.No Comments

Sampling and Testing of Intermediate and Finished Goods

Quality Control, General Topics, SOPs

The Sampling and Testing of Intermediate and Finished Goods are crucial steps in the quality control and assurance processes within manufacturing and production industries. These processes ensure that products meet the specified quality standards and conform to regulatory requirements. PURPOSE To outline a procedure to take samples of Intermediate and Finished Material. The purpose of this procedure is to outline the systematic process for sampling and testing of intermediate and finished goods to ensure they meet quality specifications and regulatory standards. SCOPE: This SOP applies to sampling of intermediate materials and Finished Materials. RESPONSIBILITIES: Production Incharge, QC Incharge and QC Analyst are responsible for representative sampling according to recommended plan...

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...