General Topics - Pharma Egg

Jun122024 by KBS.No Comments

Structure & Transport of Material in Production

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

Structure & Transport of Material in Production is the place where the dry products, liquids, capsules, cream are manufactured in their specific area according to standard procedures of GMP. Products shall be manufactured under conditions which minimize deterioration and contamination. Special environmental condition are required for certain products. Introduction These conditions should be continuously monitored and corrective action taken, where necessary. Products are manufactured at temperature 25oC and relative humidity is not more than 50%. Products which are sensitive to humidity are manufactured in special area. Dehumidifier is used for maintaining the humidity less than 50%. Movement of Materials in the Production Area According to monthly plan, on the advice of Producti...

Jun82024 by KBS.No Comments

Documentation System in Pharmaceuticals Industry

Quality Assurance, General Topics, Production, Quality Control

Effective documentation practices Documentation System in Pharmaceuticals Industry are essential for ensuring product quality, patient safety, and regulatory compliance in the pharmaceutical industry. Compliance with GDP and other regulatory guidelines is crucial for maintaining the integrity and reliability of documentation throughout the product lifecycle. OBJECTIVE : To describe the various documents which control all raw material, packaging components and finished products etc. SCOPE : This SOP covers specification and test methods of Raw materials, Intermediate / Bulk products (Inprocess), Packaging components and Finished products. It also covers Master formula, Batch processing and Packaging Instructions and registration files (factory related technical documents for product ...

Jun82024 by KBS.No Comments

SOP for Validation Requirements: Responsibilities and Definitions

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

A Standard Operating Procedure SOP for Validation Requirements: Responsibilities and Definitions pertinent to ensuring that processes, systems, or equipment meet predefined criteria for accuracy, reliability, and performance. OBJECTIVE: To define the responsibilities necessary for the successful completion of SOP for Validation Requirements: Responsibilities and Definitions program at ----------Pakistan facility. SCOPE: This policy applies to -------- manufacturing facility. It is the responsibility of --------- Validation Lead Team to assure that validation is completed. ---------- Pakistan believes that validation is the key element in assuring that the company’s quality assurance goals are met. GENERAL REQUIREMENTS: Product Validation: a. The manufacturing of a new produ...

May302024 by KBS.No Comments

Defect Classification Strategies in Pharmaceuticals

Quality Assurance, General Topics, Production, SOPs

In the pharmaceutical industry, Defect Classification Strategies in Pharmaceuticals can be classified into various categories based on their nature, severity, and impact on product quality and safety. Objective: This procedure Defect Classification Strategies in Pharmaceuticals defines the Acceptable Quality Level (A.Q.L) for tablets, capsules, and liquid products. Scope: This work instruction applies to all batches of tablets, capsules and liquid products, manufactured and packed at ____________Company plant. Responsibility: It is the responsibility of QAI (Quality Assurance Inspector) to follow this procedure. It is the responsibility of the Production Manager and QA Manager to implement this procedure. Procedure: Categories and Limits of A.Q.L: The batch is acceptable if it ...

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...