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

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...

Mar52022 by KBS.No Comments

Montelukast Sodium Testing Procedure

Testing Methods, Raw Material, SOPs

Montelukast Sodium Testing Procedure and Raw Material specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. Characters Spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, it should be white crystalline powder and determination. Solubility (i) Take approximately 0.5 gram of sample into a clean test tube containing water. Close the test tube with stopper and shake well. The sample slightly soluble in water. (ii) Take approximately 0.5 gram of sample into a clean test tube containing alcohol. Close the test tube with stopper and shake well. The sample slightly soluble in alcohol. (iii) Take approximately 0.5 gram of sample into a clean tes...

Mar52022 by KBS.No Comments

How To Test Naproxen Sodium Raw Material

Testing Methods, Raw Material, SOPs

How To Test Naproxen Sodium Raw Material specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. Characters How To Test Naproxen Sodium Raw Material Spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, it should be white to creamy crystalline powder Solubility Soluble in water and in methanol; sparingly soluble in alcohol; very slightly soluble in acetone; and practically insoluble in chloroform and in toluene. Melting point Melts at about 225 °C with determination decomposition Procedure: Grind the Naproxen Sodium sample into a fine powder in a mortar and pack the capillary tube with sample by tapping on a hard surface so as to form a...

Mar52022 by KBS.No Comments

Paracetamol Raw Material Testing By UV Method

Testing Methods, Raw Material, SOPs

Paracetamol Raw Material Testing By UV Method specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. Paracetamol Raw Material Testing By UV and Purpose This raw material specification & analysis prescribes the requirements for Paracetamol raw material Testing UV and HPLC Method. Characters Spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, determination it should be white, crystalline powder. Solubility Sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride. Identification Melting point:- 168 °C to 172 °C Procedure: Paracetamol Raw Material Testing By UV Method, Grind the Paracetamol s...

Mar52022 by KBS.No Comments

Ranitidine HCl Testing UV and HPLC Method

Testing Methods, Raw Material, SOPs

Ranitidine HCl Testing UV and HPLC Method Raw Material specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. Ranitidine HCl Testing UV and HPLC Method and Purpose This raw material specification & analysis prescribes the requirements for Ranitidine HCl raw material Testing UV and HPLC Method. Characters Ranitidine HCl Testing UV and HPLC Method is spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, it should be white to pale yellow, crystalline, practically odorless powder. Is sensitive to light and moisture. Melts at about 140º, with decomposition. Solubility Ranitidine HCl Very soluble in water; sparingly soluble in alcohol. Melt...