Production - Pharma Egg

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...

Jan292023 by KBS.No Comments

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...

Jan262023 by KBS.No Comments

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...

Jan262023 by KBS.No Comments

SOP for Production Planning and Batch Record Review

Production

This SOP for Production Planning and Batch Record Review is for assigning individual responsibilities to Q.A and Production with regard to proper entries and completion of batch records in time to ensure batch product release. This SOP for Production Planning and Batch Record Review the documented procedure for points to be checked by QA during batch record review. PURPOSE: To describe the procedure for production planning and batch record review. SCOPE: This procedure is for Quarterly / Monthly & Fortnightly / Weekly production planning of all sections of the Production Department and the documented procedure for points to be checked by QA during batch record review. RESPONSIBILITY: Production Manager. Production Pharmacist. Head of the Production Department REFERENCES: In...

Jan262023 by KBS.No Comments

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...

Jan242023 by KBS.No Comments

SOP for Tablet Compression and Granulation

Production, General Topics

SOP for Tablet Compression and Granulation, the process of particle enlargement by agglomeration technique, is one of the most significant unit operations in the production of pharmaceutical dosage forms, mostly tablets and capsules. SOP for Tablet Compression and Granulation process transforms fine powders into free-flowing, dust-free granules that are easy to compress. PURPOSE: To lay down the procedure for Tablet Compression and Tablet Granulation. SCOPE: This SOP is for all the processes from compression including the changeover for the next batch at the Production department and granulation including processing for the next batch at the Production department. RESPONSIBILITY: Execution: Operator. Checking: Production Pharmacist. REFERENCES: In-house. PROCEDURE: ...