SOPs

Standard Operating Procedures (SOPs) provides end-users with clear instructions on how to work and develop enough to ensure that all end-users can perform their tasks in a consistent and consistent manner. Many processes can be difficult, and it is important to have a balance between too few and too many points. If there are too few points, the end-user will follow their path. On the other hand, too much information and too much detail increase the risk that the end-user will struggle to understand and perform everyday steps, resulting in errors and omissions.

Sops are of different types like Quality Control SOPs, General SOPs, Production SOps, R&D, Regulatory and Validation SOPs etc

Jan312023 by KBS.No Comments

SOP for Sampling and Testing of Raw Materials

Raw Material, Quality Control, SOPs

The choice of a SOP for Sampling and Testing of Raw Materials plan should always take into consideration the specific objectives of the sampling and the risks and consequences associated with inherent decision errors. The bibliography at the end of this Annex should be consulted when justifying a sampling plan for a given purpose. All SOP for Sampling and Testing of Raw Materials operations related to sampling should be performed with care, using proper equipment and tools. Any contamination of the sample by dust or other foreign material is liable to jeopardize the validity of the subsequent analyses. Purpose:- It is established to provide the guidelines for the SOP for Sampling and Testing of Raw Materials of sterile & non sterile Raw Materials so as to get the representative ...

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. ...

Jan302023 by KBS.No Comments

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...

Jan302023 by KBS.No Comments

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...

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...

Jan292023 by KBS.No Comments

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...

Jan282023 by KBS.No Comments

Pest and Rodent Control in Pharmaceuticals

SOPs, Quality Assurance

Describes Pest and Rodent Control in Pharmaceuticals program including controls for rodents, insects, birds, pets etc. Criteria shall be describe how monitoring is conducted by the establishment or outside contractor. Also includes applicable pest control devices and their locations and chemical application. Only emulsifiable concentrate grade pesticides with known antidote shall be allows to use as per instructions mentioned in Agreement. OBJECTIVE: To lay down the procedure to Pest and Rodent Control in Pharmaceuticals within the plant. SCOPE: This SOP is applicable for pest & rodent control within the plant and the factory premises at pharmaceuticals. RESPONSIBILITY: QA Officer. Admin Officer. ACCOUNTABILITY: QA Head shall be accountable for the implementation of th...

Jan232023 by KBS.No Comments

Product / Batch Change Over Procedure

Production, SOPs

Product / Batch Change Over Procedure turn around time is the time between the production of the last good part of the current batch and the first good part of the new batch. In other words, this is the time it takes you to physically check the machine and manually record the Product / Batch Change Over Procedure on each machine. Important points are given in identifying this method. Justification, review, review and approval, communication, training, implementation, and Evaluation. Product / Batch Change Over Procedure are an integral part of many manufacturing facilities. However, they also represent a loss of productivity. After all, when you're converting batches, you're not producing the product. This is further enhanced in pharmaceutical manufacturing facilities where Product / Ba...