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General Topics

Here you can read general topics related to Pharmaceuticals.

Tablet Making Process in Pharmaceuticals – Step by step guide

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...
Vendor Evaluation Procedure in Pharmaceuticals

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...
SOP for Process Change Control in Pharmaceuticals

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...
Good Personal Hygiene in Pharmaceuticals

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...
Washing and Cleaning of Laboratory Glassware

Washing and Cleaning of Laboratory Glassware

SOPs, General Topics, Quality Control
Washing and Cleaning of Laboratory Glassware isn't as simple as washing the dishes. Here's how to wash your glassware so that you won't ruin your chemical solution or laboratory experiment. For the Washing and Cleaning of Laboratory Glassware detergent and tap water are neither required nor desirable. You can rinse the glassware with the proper solvent, then finish up with a couple of rinses with distilled water, followed by final rinses with deionized water. Purpose:- The procedure is established to ensure the utmost cleanliness of the laboratory glassware for carrying out successful assays and tests without interference from the residues of the previous analysis. It is necessary to ensure the quality of future products handled in the equipment to prevent cross contamination and as a...
Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions

Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions

SOPs, General Topics, Quality Control
Professional quality solutions are possible when high quality and fresh chemicals and solvents are used, and meticulous procedures are followed. Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions of the reagents used in science are in the form of solutions which need to be purchased or prepared. Purpose:- To lay down a procedure for the Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions of shelf life to volumetric solutions and laboratory reagents used for chemical analysis. Scope of Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions:- This SOP is applicable to all laboratory reagents and volumetric solutions used in analytical work for Preparation and Assigning Shelf Life to Reagents & Volumetric Soluti...
Air Changes and Product Data Analysis

Air Changes and Product Data Analysis

Production, General Topics, SOPs
Air Changes and Product Data Analysis uses in Pharmaceuticals is the use and application of data analytics in the pharmaceutical industry. Integrating big data analytics solutions into pharmaceutical manufacturing processes allows companies to gain valuable insights to accelerate and optimize production. Standard operating procedure Air Changes and Product Data Analysis to measure the air velocity and air changes per hour in CFM in classified area. The measured air quantity shall not be less than the designed air quantity and the calculated air changes shall not be less than the designed air changes per hour.   Objective :- To ensure the air changes in sterile areas (clean Room) as per specification and To analyses product related data for conformance to specifications, determ...
Product Processes and Quality of In Process Material

Product Processes and Quality of In Process Material

Quality Control, General Topics, SOPs, Testing Methods
The purpose of a Product Processes and Quality of In Process Material system is to provide staff and management with objective insight into the process and related work products. Your process and product quality approach supports the delivery of high-quality products by providing project staff and managers at all levels with appropriate visibility into the process and related work products throughout the life of the pharmaceuticals. Product Processes and Quality of In Process Material Objective:- To ensure compliance of Product Processes and quality of in process material. Responsibility:- Section Supervisor Production Manager QA Incharge Procedure:- Issuance of Raw Material & Packaging Components Check the product name, strength, printing quality and quantity o...
SOP for Sanitation in Pharmaceuticals

SOP for Sanitation in Pharmaceuticals

Production, General Topics
This applies to the general area, tablet production area, manufacturing area, compression/packaging area, clean area, and pharmaceutical cleaning frequency. Procedures for transferring cleaning agents and disinfectants into and out of clean areas (including procedures for disinfection of disinfectants). SOP for Sanitation in Pharmaceuticals stands for cleaning using the dryer. Cleaning the entire floor using a 2.5% disinfectant solution. (disinfectant) Coving, corner cleaning of the entire area using a wet mop. Clean the tube light fixture using a wet mop followed by a clean dry mop. PURPOSE : To lay down the procedure for sanitation in Pharmaceuticals. SCOPE: This is applicable to the general area, tablet production area, manufacturing area, compression/packaging area, clean area, &am...
SOP for the Manual Capsule Machine Operation and Cleaning

SOP for the Manual Capsule Machine Operation and Cleaning

Production, General Topics
SOP for the Manual Capsule Machine Operation and Cleaning is split up into 2 main types, semi-automatic and fully automatic. Semi-automatic machines require the operator to assist with production by moving the filling plates between the different production stages. SOP for the Manual Capsule Machine Operation and Cleaning the end of the day or product, changeover remove any visible material from the machine with the help of a nylon brush, vacuum cleaner, and jet of compressed air. PURPOSE: To lay down the operating procedure for the Operation and cleaning of the Manual cap machine. SCOPE: This shall be applicable to the operation and Cleaning of Manual Capsule machines in the area of Production. RESPONSIBILITY: Supervisor/ Machine Operator. Production Pharmacist. Manager-Pr...