General SOPS - Pharma Egg

Nov152023 by KBS.No Comments

Sop for Cleaning, Mopping and Fumigation of Sterility Room

Certainly! Below is a template for a Standard Operating Procedure SOP for Cleaning, Mopping, and Fumigation of a Sterility Room. This SOP is essential for maintaining a sterile environment in facilities such as pharmaceutical or biotechnology cleanrooms. Ensure that this SOP complies with any applicable regulatory guidelines and industry standards. Additionally, adapt the template to match the specific requirements and processes of your organization. Regularly review and update the SOP to reflect any changes in procedures or equipment. PURPOSE To describe the procedure for cleaning, mopping and fumigation of the sterility test Lab to avoid area / equipment generated Microbial contamination in sterility test Lab. SCOPE This procedure applies to sanitization by disinfecting mopping an...

Nov152023 by KBS.No Comments

Sterility Test Validation Standard Operating Procedure

Microbiology, General SOPS, SOPs

Sterility Test Validation Standard Operating Procedure is a crucial document that outlines the step-by-step process for validating the sterility testing procedures used in a pharmaceutical or biotechnology setting. This SOP ensures that the sterility testing methods are reliable, accurate, and consistent. Here's an outline that you can use to create an SOP for Sterility Test Validation: PURPOSE To assure that sterility test with direct inoculation will produce the same results when tested as per Sterility Test Validation Standard Operating Procedure. State the purpose of the SOP, which is to establish a standardized procedure for the validation of sterility testing methods. SCOPE This Sterility Test Validation Standard Operating Procedure is applicable for sterility of products. Define...

Nov82023 by KBS.No Comments

SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area

Microbiology, General SOPS, SOPs

PURPOSE To lay down a qualification SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area. The role of manufacturing department and quality control departments is to perform environmental monitoring. SCOPE This SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area is applicable to Sterility testing area of microbiology lab and sterile injectable facility. The scope for aseptic processing is suitable for sterility testing field of sterile injectable capacity and microbiology laboratory. The SOP is mainly applied for the qualified individuals only for controlling the entry, exit and aseptic area gowning. RESPONSIBILITIES Microbiologist and all personnel are responsible to full fill the qualification requirements while entering sterile area.&...

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 ...

Nov72023 by KBS.No Comments

SOP for Preservative Efficacy Test

Microbiology, General SOPS, SOPs

A Standard Operating Procedure (SOP) for a Preservative Efficacy Test outlines the step-by-step process for conducting tests to determine the effectiveness of preservatives in cosmetic, pharmaceutical, and other products. This test is crucial to ensure that products remain safe and free from microbial contamination throughout their shelf life. Here's a sample SOP for a Preservative Efficacy Test: PURPOSE To provide guidelines for preservative efficacy test and determine the effectiveness of preservatives in products by assessing their ability to inhibit the growth of microorganisms. SCOPE This SOP for Preservative Efficacy Test is applicable for preservatives used for aseptic filling to inhibit the growth of microorganisms in product. This SOP applies to all personnel involved in condu...

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 pharmaceu...

Nov22023 by KBS.No Comments

Guidelines for Equipment Installation Qualification (SOP)

Quality Control, General SOPS, SOPs

The purpose of this procedure is to outline the Guidelines for Equipment Installation Qualification (SOP) requirements and acceptance criteria for the critical equipment serving to Pharmaceutical Limited facility. This Standard Operating Procedure outlines the guidelines for Equipment Installation Qualification (IQ) at pharmaegg.com. Guidelines for Equipment Installation Qualification (SOP) is a critical step in ensuring that newly acquired equipment is properly installed, calibrated, and ready for use. Adhering to these guidelines guarantees the integrity, accuracy, and reliability of the equipment, contributing significantly to the quality and consistency of our research and development efforts. OBECTIVE: Guidelines for Equipment Installation Qualification (SOP) location and purpose of...

Nov22023 by KBS.No Comments

Reverse Osmosis Water System (SOP)

General SOPS, General Topics, Quality Control, SOPs

1.0 RAW WATER Reverse Osmosis Water System (SOP) is that water, which is obtained from well or any reservoir. Reverse Osmosis Water System (SOP) contains minerals, salts chlorides, sulfates, calcium & magnesium etc. Microbial count of raw water, which may be used for drinking, is 500CFU/ml. The ingredients present in this water may be incompatible with our medicine and can disturb the stability of product so, purification of this water is required. 2.0 PURIFIED WATER Purified water is that water which is obtained by distillation, ion exchange treatment, reverse osmosis or other suitable process from suitable potable water. It contains no added substances Purified water is required for manufacturing of quality medicine in Searle P...

Nov22023 by KBS.No Comments

General Descriptions of Quality Control Department

Quality Control, General SOPS, General Topics, SOPs

1.0 INTRODUCTION General Descriptions of Quality Control Department is a concept which stocks to produce a perfect product by series of measure design to prevent and eliminate errors at different stages of products. It is the most essential component of the drug industry and quality control may be easy for a well equipped and qualified staff i.e. as the necessary facilities including analytical instruments like HPLC, UV, K.F, and other necessary instruments as well as required chemicals. Q.C is essentially concerned with routine examination of a limited range of raw material intermediate and finished products. The laboratory is usually required to carryout the following type of testing, chemical analysis, instrumental analysis, general microbiological testing and r...

Nov22023 by KBS.No Comments

Material Management Procedures (SOP)

General SOPS, General Topics, Raw Material, SOPs

Standard Operating Procedures (SOPs) are essential documents in any organization, including those in the pharmaceutical industry. Material management SOPs provide guidelines and instructions for the proper handling, storage, tracking, and disposal of materials used in manufacturing processes. Here's a general outline for creating material management procedures (SOP) tailored to your organization's specific needs. The Marketing Division will forward the requirement of local and export products, bonus. Deals samples, and toll-manufactured products on the prescribed Customer order from the Production Manager, 120 days in advance of the finished stock. Requirement for acceptance and approval. The P.M. will approve the customer order and forward it to the Production Division. The produc...