All Posts - Pharma Egg

Jan292023 by KBS.No Comments

Air Changes and Product Data Analysis

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...

Jan262023 by KBS.No Comments

Zinc Oxide Testing by Alternate Method

Testing Methods

USP is updating the General Chapter Zinc Oxide Testing by Alternate Method Determination of the monograph to include ion chromatography as a method for the assay. Zinc oxide is used in various skin care creams, drugs, and drug products. The ion chromatography analysis involves the separation of zinc followed by a post-column reaction using 4-(2-pyridylazo) resorcinol (PAR) reagent and subsequent detection at 530 nm wavelength. Sample preparation consisted of 0.1868 g of sample dissolved in 10 mL 6 mol/L HCl and made up to 100 mL with ultrapure water. PURPOSE This Raw material Specification & Analysis prescribes the requirements for Zinc Oxide Testing by Alternate Method, which is one of the components of a Capsule, tablet, and AX tablet. SCOPE It is applicable in the Material, Pr...

Jan262023 by KBS.No Comments

Meloxicam 7.5mg Injection Testing by UV Method and In House Method

Testing Methods

Meloxicam testing by UV method and In House method 2, meloxicam is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by the breakdown of the joint lining) and rheumatoid arthritis (arthritis caused by inflammation of the joint lining) Meloxicam 7.5mg Injection Testing by UV Method and In House Method is also used to relieve pain, tenderness, swelling, and stiffness caused by juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older. . Meloxicam is in a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). It works by blocking the body's production of substances that cause pain, fever, and inflammation. PURPOSE To describe the operational procedure Meloxicam 7.5mg In...

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: ...

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...