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General Topics

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SOP for Change Control in Pharmaceuticals

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...
General Instructions for Instruments in Pharmaceuticals (SOP)

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...
SOP for Installation Qualification Protocol and Formats

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 ...
SOP for BET Validation by Gel Clot Method

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 ...

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...
Reverse Osmosis Water System (SOP)

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...
General Descriptions of Quality Control Department

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...
SOP for Calibration and Operation of Cool Incubator

SOP for Calibration and Operation of Cool Incubator

Instrument SOP, General Topics, Microbiology, SOPs
This Statement of Purpose outlines the procedures and guidelines for the proper SOP for Calibration and Operation of Cool Incubator at pharmaegg.com. The cool incubator is essential for maintaining low-temperature conditions for various biological and chemical experiments, making it crucial to adhere to strict calibration and operational protocols. Adhering to these protocols ensures accurate and reliable results, contributing significantly to the scientific integrity of our research activities. PURPOSE To describe procedures for operation and calibration of Cooled Incubator. The primary objective of this SOP for Calibration and Operation of Cool Incubator is to establish a standardized approach for the calibration and operation of the cool incubator. By following these guidelines, we ai...
SOP for Operation of Air Sampler

SOP for Operation of Air Sampler

Instrument SOP, General Topics, SOPs
This SOP for Operation of Air Sampler outlines the procedures for the proper operation of the air sampler to ensure accurate and reliable air quality monitoring within the [Your Organization Name] facility. PURPOSE To describe the procedure for the operation of the air sampler. SCOPE This procedure is applicable for the operation of an air sampler at the microbiological laboratory of QCD and the Manufacturing area. This SOP applies to all personnel responsible for operating the air sampler within the organization. RESPONSIBILITIES & AUTHORITIES It is the responsibility of microbiologist to follow this SOP as it is written It is the responsibility of QC manager to review and update this SOP as necessary and to ensure that this SOP is followed in its entirety. REFERENCES ...
Material Management Procedures (SOP)

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...