Quality Assurance - Pharma Egg

Oct262023 by KBS.No Comments

Equipment Operational Qualification (SOP)

SOPs, Production, Quality Assurance, Quality Control

Equipment Operational Qualification (SOP) is the process, which establishes through verification and documentation that the equipment is capable of operating within established limits and tolerances. This demonstration of basic performance must involve operational aspects of the equipment that will be routinely used in manufacturing. OBECTIVE: This guideline defines the minimum requirements for facility regarding the Equipment Operational Qualification (SOP) which must be performed following Installation Qualification (IQ) and prior to process, system qualification. SCOPE: All critical equipments will require successful completion of Operational Qualification (OQ). For New Equipment: OQ must be completed prior to manufacture of product for process validation. For existing equi...

Oct262023 by KBS.No Comments

Cleaning Validation Standard Operating Procedure

SOPs, Production, Quality Assurance

Equipment changeover Cleaning Validation Standard Operating Procedure must be validated for all major and minor product contact equipment used for multi-product production, subdivision and sampling of drug products and in process materials. INTRODUCTION Validation of cleaning procedures has generated considerable discussion since agency documents, including the Inspection Guide for Bulk Pharmaceutical Chemicals and the Biotechnology Inspection Guide, have briefly addressed this issue. These Agency documents clearly establish the expectation that cleaning procedures (processes) be validated. This guide is designed to establish inspection consistency and uniformity by discussing practices that have been found acceptable (or unacceptable). Simultaneously, one must recognize that for cleani...

Oct252023 by KBS.No Comments

SOP for Purified Water & Potable Water Testing

SOPs, Microbiology, Quality Assurance

Formula: H2O Molecular Weight: 18 Source of Information: WHO/BP/USP Purpose: To avoid microbial contamination in products. Liquid as well as solids. Water Sampling Point Place Tests and Frequency Purpose SP-1 Between Turbine and Tank Chemical and Microbiological: Once in a Month To prove the chemical quality and microbiology of the well water SP-2 Between Tank and Sand Filter Chemical and microbiological. Fortnightly To prove the chemical quality of the well water and the change of the microbial Quality in the Tank SP-3 After Hardness Stabilizing System (Anti-scaling System) Chemical: Twice a week To prove the effect of the Hardness stabilizing system SP-4 Primary storage tank Chemical: Twice a week To prove the efficacy of 1st two membra...

Oct252023 by KBS.No Comments

Standard Operating Procedure for Product Development

Quality Assurance, Production, SOPs

Developing a Standard Operating Procedure for Product Development is crucial for ensuring consistency, quality, and efficiency in the development process. Here's a general outline for creating an SOP for product development. Please tailor this outline to fit the specific needs and processes of your organization and industry: PURPOSE To define and document a procedure for pharmaceutical product development. SCOPE This procedure applies to development of new pharmaceutical product. RESPONSIBILITIES The Managing Director (MD / CEO) approves the initiation of the project. New Product Technical Committee (NPTC) is responsible for designing and documenting inputs and outputs of design and development activities. This committee comprises of: Executive Director (Technical) ...

Oct242023 by KBS.No Comments

SOP for the preparation of Master Formula Record

SOPs, Production, Quality Assurance, Quality Control

SOP for the preparation of Master Formula Record Some basic explanations and instructions were given for preparing various documents required by Good Manufacturing Practice guidelines from WHO and from several regulatory authorities. GMP guidelines include the requirements for documents (individual), documentation (the systems and formats for documents), and documenting (recording) of production and control activities. Most GMP guidelines provide the same or very similar information as the principles of Good Manufacturing Practice are now international in scope. In this guidance document, the requirement for master manufacturing instructions and the requirements as given in different GMP documents, Terms for Master Formula (MF) WHO identifies manufacturing instructions as “Master Formula. ...

Mar62023 by KBS.No Comments

SOP for Preparation of Batch Manufacturing Record (BMR)

Quality Assurance, General Topics, SOPs

A batch Manufacturing Record (BMR) is a document that contains all the necessary information related to the manufacturing process of a specific batch of a product. The SOP for Preparation of Batch Manufacturing Record (BMR) is a critical document that provides a comprehensive and detailed account of the manufacturing process and is used to ensure that the batch is manufactured in accordance with established procedures and specifications. Overall, the BMR should be a complete and accurate record of the manufacturing process for a specific batch of a product. It should provide all the information necessary to ensure that the batch is manufactured in accordance with established procedures and meets the required quality standards. PURPOSE The purpose of this SOP is to set forth the procedure...

Mar32023 by XhaamiNo Comments

Relative Humidity vs Absolute humidity vs Specific humidity

SOPs, General Topics, Production, Quality Assurance

Relative humidity, absolute humidity, and specific humidity are three important atmospheric parameters that describe the amount of moisture in the air. Relative Humidity vs Absolute humidity vs Specific humidity Although all three are related to the moisture content of air, they each measure different aspects of it. Relative humidity refers to the amount of water vapor in the air compared to the amount of water vapor the air can hold at a given temperature. It is expressed as a percentage, with 100% relative humidity meaning that the air is saturated and can no longer hold any additional moisture. Absolute humidity refers to the actual amount of water vapor present in the air, measured in units such as grams per cubic meter (g/m3) or grains per cubic foot (gr/ft3). Absolute humidity ...

Feb232023 by KBS.No Comments

SOP for Procedure for Process Change Control

Quality Assurance, General Topics, SOPs

Process change control is a crucial part of pharmaceutical manufacturing operations as it ensures that any modifications made to the manufacturing process are evaluated and documented to ensure product quality, safety, and efficacy. SOP for Procedure for Process Change Control is essential to follow a well-defined change control process in the pharmaceutical industry to ensure that any modifications made to the manufacturing process are thoroughly evaluated, documented, and controlled to ensure product quality, safety, and efficacy. PURPOSE: To control process variability To operate the process smoothly SCOPE: This procedure is to be followed while controlling process change in the production department. RESPONSIBILITY: Chief Executive Officer Quality Control Manager Quali...

Feb82023 by KBS.No Comments

Standard Operating Procedure on Sop in a Pharmaceutical Industry

General Topics, Quality Assurance, Quality Control, SOPs

A Standard Operating Procedure on Sop in a Pharmaceutical Industry is a detailed, written instruction that outlines the steps required to perform a specific activity within a pharmaceutical industry. It provides a standard and consistent approach to processes, ensuring that they are performed accurately, consistently, and in compliance with regulatory requirements. In the pharmaceutical industry, SOPs are critical to ensure the quality and safety of drug products, as well as to ensure compliance with regulatory requirements. Each SOP should include a clear description of the steps involved, the personnel responsible for each step, and the equipment and materials required. It should also include clear instructions on how to perform each step, as well as on how to document and record t...

Feb82023 by KBS.No Comments

Risk Management in Pharmaceuticals

SOPs, General Topics, Quality Assurance, Quality Control

Risk management in pharmaceuticals is the systematic process of identifying, assessing, and prioritizing potential risks associated with the development, production, and distribution of drugs, and implementing measures to mitigate these risks. This involves identifying and assessing the potential risks associated with each stage of the drug development process, from the initial discovery and development of new compounds to the post-market monitoring of drugs once they are on the market. Risk mitigation strategies may include changes to the drug's formulation, manufacturing processes, labeling, or distribution methods, as well as increased monitoring and clinical testing. The goal of risk management in pharmaceuticals is to ensure that drugs are safe and effective for patients, while also b...