IPQA Person plays a very important role in the quality of drugs or products during manufacturing. She/ He is responsible for carrying out all the processes as per standard operating procedures during manufacturing to ensure quality. The line clearance stage is the very crucial stage before starting a product. So the role of the IPQA … Read more
1.0 Objective: To lay down a procedure for the operation of the strip pack machine.2.0 Scope: This standard operating procedure is applicable to the operation of the strip pack machine used in the production department.3.0 Responsibility: Officer and Executive – for implementation of this procedure.Manager Production is responsible for overall compliance with this procedure. 4.0 Procedure: 4.1 Machine Setting:Ensure … Read more
Six Sigma is an extremely disciplined activity that focuses on growing and giving close to excellent products and services. Six Sigma focuses on what’s necessary for the client. It reduces method variation defects, so nearly all the product or services provided meet client expectations. Six Sigma has been utilized by some of the world’s most … Read more
1.0 Objective: To lay down a procedure for the operation of Colloidal Mill.2.0 Scope: This standard operating procedure is applicable to the operation of Colloidal Mill in the production area.3.0 Responsibility: Officer, Executive – To implement this procedureHead of Department – To overall compliance with this procedure 4.0 Procedure:4.1 Operation of colloidal mill:4.1.1 Ensure cleanliness … Read more
Good Laboratory Practice (GLP) is a set of guidelines that helps ensure the quality and reliability of pharmaceutical laboratory data. These GLP guidelines are important because they help to prevent errors and they also ensure that data collected during laboratory testing is accurate and consistent. Understanding GLP guidelines in Pharmaceuticals: Good Laboratory Practice (GLP) guidelines … Read more
1.0 Objective: To lay down a procedure for the operation of Multimill.2.0 Scope: This procedure is applicable to the operation of Multimill located in the manufacturing area.3.0 Responsibility:Officer, Executive – To the implementation of this procedureManager – For overall compliance with this procedure 4.0 Procedure:4.1 Machine setting4.1.1 Ensure that the machine is cleaned before setting.4.1.2 … Read more
Pharmaceutical gels are semisolid preparations that contain one or more medicines in a hydrophobic and hydrophilic base. Gels are made using suitable gelling agents, and may also contain antioxidants, preservatives, and stabilizers. When applying gels to large open wounds or severely injured skin, it is important that the gel is sterile. Types of Gels In … Read more
1.0 Objective: To lay down a procedure for checking balance eccentric accuracy. 2.0 Scope: The procedure applies to the balance eccentric accuracy in the production area. 3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Check the cleanliness of the weighing balance.4.2 Calibrate and operate the weighing balance of 200 gm,3000 gm, … Read more
Inhalation preparations, specifically Pressurized Metered-Dose Preparation (MDI) are liquid or solid dosage forms intended for administration as vapors or aerosols to the lung to obtain a local or systemic effect. They contain solutions or dispersions of one or more active ingredients that can be dissolved or dispersed in a suitable vehicle. Inhalation preparations intended to be administered … Read more
1.0 Objective: To lay down a procedure for the operation of the Vacuum cleaner. 2.0 Scope: This procedure applies to the operation of vacuum cleaner in the production department. 3.0 Responsibility: Operator, Officer, Executive – to implement this procedureManager – to overall compliance with this procedure 4.0 Procedure: 4.1 Ensure the cleanliness of the vacuum cleaner4.2 Bring … Read more
Good manufacturing practice and current good manufacturing practice are both terms correlated with each other. Both GMP and cGMP same purpose and functionality, They work together to achieve the quality, efficacy, and Productivity of a product’s goods. GMP and cGMP: GMP stands for good manufacturing practice, while cGMP stands for current good manufacturing practice. What … Read more
1.0 Objective: To lay down a procedure for cleaning and utilization of FBD Finger Bag and filter bag in the production department. 2.0 Scope: The procedure is applicable to the cleaning and utilization issuance of FBD Finger Bags in the Production department. 3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Take FBD finger … Read more
Quality Assurance person shall ensure the following Checklist For BMR Release. The header section of the checklist must contain the Product brand name, Product Generic name, Batch Number, Batch size, BMR number, and QA release number. Checklist for BMR Release Note: The Footer section for the Checklist for BMR must be checked by and approved … Read more
1.0 Objective: To lay down a Procedure for the operation of Metal detector and vertical deduster.2.0 Scope: This procedure is applicable to the operation of Metal detector and vertical deduster in the production area.3.0 Responsibility: Officer to implement this procedure Department Head responsible for overall compliance with this procedure 4.0 Procedure:4.1 Machine setting4.1.1 Ensure cleanliness … Read more
High-Performance Liquid Chromatography (HPLC) is used in pharmaceuticals for the analysis of drug mixture and their components. HPLC is reverse-phase Liquid Chromatography. This technique is used for thermal labile, high molecular weight peptides, and non-volatile compounds. The main purpose of HPLC is used to examine the mixture for its identification, impurities, and purification. The mixture … Read more
1.0 OBJECTIVE: To lay down a procedure for cleaning, operation, and calibration of friability test apparatus. 2.0 SCOPE: This procedure is applicable to the cleaning, operation, and calibration of the friability test apparatus used in pharmaceutical manufacturing. 3.0 RESPONSIBILITY: Officer, Executive – Production DepartmentManager – Production Department, QA Officer – In the process 5.0 PROCEDURE: 5.1 Cleaning5.1.1 Remove … Read more