General Topics - Pharma Egg

Feb282024 by KBS.No Comments

SOP for Art Work of New Pharmaceuticals Products

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

Creating the SOP for Art Work of New Pharmaceuticals Products artwork for new pharmaceutical products involves designing the visual elements that will appear on their packaging. This includes things like the logo, brand name, dosage information, and any images or graphics. The goal is to make the packaging informative, attractive, and compliant with regulations, while also reflecting the brand's identity. Think of it as designing the face of the product that customers will see on the shelves. INTRODUCTION The artwork serves multiple vital functions. Firstly, it communicates essential information to healthcare professionals and consumers, ensuring safe and effective use of the medication. Secondly, it plays a significant role in brand recognition and differentiation, helping the product s...

Feb262024 by KBS.1 Comment

Batch Document Review and Inprocess Checks SOP

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

Batch Document Review and Inprocess Checks SOP are essentially a way to ensure quality and consistency during the manufacturing process. Here's a simplified explanation: Batch Document Review: Before making a batch of products, you review all the documents related to the manufacturing process. This includes recipes, instructions, and quality standards to ensure everything is correct and ready to go. In-process Checks: While making the products, you perform regular checks to make sure everything is going according to plan. This could involve measuring ingredients, checking temperatures, or inspecting the product at different stages to catch any issues early on. These steps help maintain quality control and ensure that the final products meet the desired standards. OBJECTIVE ...

Feb262024 by KBS.No Comments

SOP for General Description of Finished Products

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

SOP for General Description of Finished Products provides a basic overview of the products once they're fully made. It typically includes details like what the product looks like, its size, color, materials used, and any unique features or characteristics. Think of it as a snapshot that helps someone understand what the product is all about without getting into too much technical detail. INTRODUCTION A finished product is any pharmaceutical product that has under gone all stages of production, including packing and labeling. The efficacy and safety of a product can only be assured by analytical monitoring of its quality therefore, the overall purity of a product must therefore, be assessed throughout its manufacturing, storage, distribution and use. The objective can easily be achi...

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

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.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...

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...