Production - Pharma Egg

Oct252023 by KBS.No Comments

Standard Operating Procedure for Product Development

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. ...

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 ...

Feb42023 by XhaamiNo Comments

Tablet Making Process in Pharmaceuticals – Step by step guide

General Topics, Production

The tablet making process in the pharmaceutical industry is a crucial and complex procedure that involves several steps to ensure the final product is of high quality and meets the required standards. From the selection of active ingredients and excipients to inspection and packaging, each step plays an essential role in determining the quality of the final tablet. In this article, we will delve into the complete tablet manufacturing process in pharmaceuticals, providing an in-depth look at each step, from blend preparation to stability testing. With a focus on precision and expertise, this guide will provide a comprehensive overview of the art of tablet making in the pharma industry. The process of making tablets in the pharmaceutical industry typically involves the following steps: Ste...

Feb32023 by KBS.No Comments

Vendor Evaluation Procedure in Pharmaceuticals

Production, General Topics, SOPs

Vendor Evaluation Procedure in Pharmaceuticals qualification is the process of determining whether a vendor can provide the required goods or services to the standards that the purchasing company requires. This article describes in detail how to qualify raw material vendors, packaging vendors, and service providers. This also explains vendor evaluation and re-evaluation. The vendor Evaluation Procedure in Pharmaceuticals assessment is a process that businesses can use to determine whether prospective vendors and suppliers will be able to meet their organizational standards and obligations once they are under contract. The ultimate goal is to secure a portfolio of low-risk, best-in-class vendors and suppliers. PURPOSE: It is intended to provide a system to qualify a vendor /supplie...

Jan312023 by KBS.No Comments

SOP for Process Change Control in Pharmaceuticals

Production, General Topics, Quality Control, SOPs

A formal system by which qualified persons or Subject SOP for Process Change Control in Pharmaceuticals matter Expert of different departments review proposed or actual changes that might affect a validated status of facilities, system, equipment, Document or processes. SCOPE:- This procedure is to be followed while controlling process change in Pharmaceuticals Plant. OBJECTIVE:- To control process variability To operate the process smoothly. RESPONSIBILITY:- Plant Manager Quality Control Manager Quality Assurance Manager Inventory Control Manager Production Manager Maintenance Incharge Critical Process: Following are the critical processes in which change need control in order to control Process variability & for smooth operation: Change of...

Jan312023 by KBS.No Comments

Sampling and Testing of Packing Materials

Testing Methods, Production, Quality Assurance, Quality Control

The Sampling and Testing of Packing Materials should take account of at least the following: the quantity received, the quality required, the nature of the material (e.g. primary packaging materials and/or printed packaging materials), the production methods, and what is known of the Quality Assurance system of the Sampling and Testing of Packing Materials manufacturer based on audits. The number of samples taken should be determined statistically and specified in a sampling plan. Sampling and Testing of Packing Materials is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the whole cannot be based on tests which have been carried out on non representative samples. Correct sampling is thus an essential part of a system of Quality Assurance....

Jan312023 by KBS.No Comments

Good Personal Hygiene in Pharmaceuticals

Production, General Topics, Quality Control, SOPs

Good Personal Hygiene in Pharmaceuticals is required in the pharmaceutical industries to protect the product and avoid any contamination that affects the quality of the medicinal product. Good Personal Hygiene in Pharmaceuticals Individuals are responsible for the quality of medicinal products and may therefore be collectively referred to as "staff". Purpose:- The purpose of this procedure is to prevent contamination of Products prepared at the Surge Plant by employees working or Vice Versa. Scope Good Personal Hygiene in Pharmaceuticals:- This procedure is applicable to all the Good Personal Hygiene in Pharmaceuticals working at, .................located HSE Statement:- N.A Responsibility:- Officer QC/QA in coordination with Manager QA/QMR will ensure that SOP has been successfull...

Jan302023 by KBS.No Comments

Sampling and Testing of In process and Finished Products

Quality Control, Product, Production, SOPs, Testing Methods

The objective of in Sampling and Testing of In process and Finished Products is to verify that all applicable specifications and requirements pertaining to product are fulfilled and to prepare corresponding documents so as to check that testing parameters met the intended specifications and requirements through out the production run. Purpose:- This SOP is established to provide the guidelines for the sampling & testing of in process and finished products so as to get the representative sample of the whole batch for analysis. Sampling and Testing of In process and Finished Products Additionally, the objective of the in process & final testing is to provide objective evidence of product conformance to specification and continued effectiveness of the quality management system. ...

Jan292023 by KBS.No Comments

Measuring and Monitoring of Noise Level

SOPs, Production, Quality Assurance

Measuring and Monitoring of Noise Level is a process to measure the magnitude of Noise in industries and residential area. Data collected from Noise level monitoring & Testing helps us to understand trends and action can be taken to reduce noise pollution. The Measuring and Monitoring of Noise Level of noise from a stationary source is carried out near the source where sound pressure is higher from the source compared to all other noise. The sound measured nearby the source tells the noise generated by the source. Sound level measured from specific distance from sound source can be used to calculate sound power output. Similarly, Measuring and Monitoring of Noise Level Sound power of the source can be used to calculate pressure level for the sound at other locations away from the...