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
The term HEPA means “High-efficiency Particulate Air,” sometimes called “High-Efficiency Particulate Arrestance,” and what that basically means is that it’s a special kind of filter that captures microscopic particles. A HEPA filter removes particles like dirt, pollen, spores, pet dander, bacteria, smoke, and particulates that come from outdoor pollution. Types of HEPA Filters? Another issue … Read more
1.0 OBJECTIVE: To lay down the procedure for the Growth Promotion Test in Microbiology Laboratory. 2.0 SCOPE: This SOP applies to carry out the procedure of Growth promotion test in the Microbiology Laboratory. 3.0 RESPONSIBILITY: 3.1 Executive – to Provide training to new joiners. 3.2 Microbiologist3.2.1. To perform activity and preparation of SOP.3.2.2. Keep data as GDP. … Read more
Blenders play a significant role in mixing ingredients in pharmaceuticals. Choosing the right types of blenders is crucial, so we select specific blenders among the different types available for use in pharmaceutical manufacturing according to our requirements. Blenders are used in pharmaceuticals after the granules manufacturing in the production section. Granules are mixed with different … Read more
1.0 Aim: To lay down the standard operating procedure for operation and cleaning of infrared thermometer 2.0 Objective: This SOP is applicable for the operation and cleaning of infrared thermometer 3.0 Responsibility 3.1 Well Trained worker / Operator shall be responsible for operating it as per the given procedure3.2 Officer Production is responsible for the implementation of this SOP.3.3 … Read more
Air is one of the major sources of contamination for pharmaceutical products. That is why the design, monitoring, and maintenance of the AHU (Air Handling Unit) are essential to increase its efficiency and capacity as per GMP (Good Manufacturing Practices). Important tips are given here to follow good practices for an Air Handling Unit. Tips … Read more
Read about the Standard Operating Procedure for a Refrigerator, including its objectives, scope, responsibilities, accountabilities, operations, annexes, and abbreviations. 1.0 OBJECTIVE: To lay down a procedure for the Operation of Refrigerator. 2.0 SCOPE: This procedure is applicable to the Operation of the Refrigerator in the microbiology lab. 3.0 RESPONSIBILITY: Microbiologist for implementation of this SOP Head/ … Read more
Recall and complaints both are different things that are used for marketed products. Recall means a company’s removal and correction of a marketed product that the FDA considers to be in violation of GMP. The Recall does not include market withdrawals. Whereas for product Complaints is not good things. It shows customer dissatisfaction with the manufacturer’s … Read more
1.0 OBJECTIVE: 1.1 Objective of this Standard Operating Procedure is to provide guidelines for the Cleaning and Operation of the Polarimeter. The fundamental principle of polarimetric analysis is based on the existence of optical activity in substances, ie. The ability of a substance to rotate plane-polarized light. 2.0 SCOPE: 2.1 Standard Operating Procedure is applicable … Read more