General Topics - Pharma Egg

Jan282024 by KBS.No Comments

Sampling and Testing of Intermediate and Finished Goods

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...

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...

Dec12023 by KBS.No Comments

General Instructions for Instruments in Pharmaceuticals (SOP)

Instrument SOP, General Topics, Quality Assurance, SOPs

General Instructions for Instruments in Pharmaceuticals (SOP) emphasizing the importance of proper instrument handling and usage to ensure accuracy, reliability, and safety. INTRODUCTION Identification and analysis of different product are made by different technique either by physical or chemical method, involving a specified machinery called Instrument are used at different stages of the product up to finished form. INSTRUMENTAL METHOD The method dependent upon measurement of an electrical property and those based upon determination of the extent to which radiation is absorbed or upon assessment of intensity of emitted radiation, all require the use of suitable instrument e.g. Polarimeter, Spectrophotometer etc. and in consequence such method are referred to as INSTRUMENTAL METHOD. E...

Dec12023 by KBS.No Comments

SOP for Installation Qualification Protocol and Formats

Instrument SOP, General Topics, Production, Quality Assurance, Quality Control

SOP for Installation Qualification Protocol and Formats is a critical phase in the validation process for equipment, systems, and utilities in regulated industries like pharmaceuticals, biotechnology, and medical devices. An IQ protocol is a document that outlines the procedures and criteria for the installation and verification of equipment. Below is an outline of an Installation Qualification Protocol along with suggested formats for key sections: INTRODUCTION Installation Qualification (IQ) is the process, which establishes through verification and documentation that the <Name of equipment> exists and is installed according to specification. Verification of appropriate documentation, such as, SOPs, drawings, repair parts lists, calibration methods, etc. for each piece of filter ...

Nov82023 by KBS.No Comments

SOP for BET Validation by Gel Clot Method

Microbiology, General SOPS, General Topics, SOPs

Pharmaegg.com, I am writing this Statement of Purpose to outline the purpose and procedures involved in the validation of endotoxin testing using the Gel Clot Method as per the requirements of the United States Pharmacopeia (USP) and other relevant regulatory guidelines. I am committed to ensuring the accuracy, reliability, and reproducibility of endotoxin testing in our laboratory setting. Through this SOP, I aim to establish clear guidelines and protocols for the validation of the Gel Clot Method, a widely accepted technique for bacterial endotoxin testing (BET). PURPOSE This SOP for BET Validation by Gel Clot Method has been established to provide the guidelines for the validation of Gel Clot Method in Microbiological lab to ensure the quality and purity of lysate. This provides a ...

Nov32023 by KBS.No Comments

Good Manufacturing Practice (GMP)

SOPs, General SOPS, General Topics

Good manufacturing practices are the units of the principles, regulations, codes (law or professional standard), recommendations and tactics, and section of nice assurance gadgets which have to be observed with the aid of the producers to make sure that the merchandise that is constantly produced are of best well known and terrific for their meant use and cowl the manufacturing and checking out of pharmaceutical dosage shape and lively pharmaceutical ingredients, diagnostics, foods, a range of different pharmaceutical merchandise and clinical units. GMP Principles: Good manufacturing exercise tips afford preparation for manufacturing, testing, and fine assurance in order to make certain that drug product is secure for human consumption. Many nations have legislated that pharmaceutical ...