General SOPS - Pharma Egg

Jan32024 by KBS.No Comments

SOP for Environmental Risk Assessment Procedure

This SOP is to establish a systematic and standardized process for conducting environmental risk assessments to identify, evaluate, and mitigate potential SOP for Environmental Risk Assessment Procedure associated with activities, processes, or products within the organization. 1 PURPOSE of SOP for Environmental Risk Assessment Procedure The purpose of this procedure is to provide a system and instructions to assess and control occupational hazards/aspects of activities, products, and services of www.pharmaegg.com group of companies. This includes to. Evaluate the associated risks and environmental impacts using the risk assessment matrix and prioritize them. Reduce the risks by controlling hazards and environmental aspects using appropriate engineering and administrative control...

Dec92023 by KBS.No Comments

Procedure for Training of the Personnel Under cGMP Environment

General SOPS, Microbiology

Training personnel under Current Good Manufacturing Practices (cGMP) is crucial for maintaining the quality and compliance of pharmaceutical and other regulated products. Here's a general Procedure for Training of the Personnel Under cGMP Environment PURPOSE The purpose of this SOP is to describe the procedure for training of the Procedure for Training of the Personnel Under cGMP Environment at Pharmaceutical Industries Limited. Based on the identified needs, develop a comprehensive training plan. This plan should outline the training objectives, content, methods, resources, and a timeline for implementation. SCOPE The scope of this SOP pertains to all the persons working at Pharmaceutical Industries Limited. Conduct a thorough analysis to identify training needs. This may include asse...

Nov152023 by KBS.No Comments

Sop for Cleaning, Mopping and Fumigation of Sterility Room

Microbiology, General SOPS, SOPs

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...