Learn about Standard operating procedures on Leak Test Apparatus including Purpose, Scope, Responsibility, Procedure, How to perform Leak test for blister and containers and aluminum triplex, limit, Action on Failure of leak test for blister or strips, Frequency, Challenge test, Cleaning and calibration of leak test apparatus. 1.0 Purpose: To let down the standard operating … Read more
Validation of the water system is important in the pharmaceutical industry. Water is extensively used in the manufacturing process at various stages. Throughout manufacturing, water is consistently generated and distributed, making it unusable to test and analyze every quantity used in production. To ensure consistent quality standards, it’s essential to validate the treatment, generation, storage, … Read more
The pharmaceutical industry generates lots of wastewater during the production or formulation of medicines. So it is very important to treats this wastewater by using various techniques. Water purification technology is used to eliminate solids from liquids. The impure solids can be coarse, suspended, colloidal, and dissolved. In the purification process, they need to be … Read more
The Drugs and Cosmetics Rules 1945 is the set of rules under the Rules of Drugs and Cosmetic Act 1940, which keep the provisions for the classification of medicine. Below are the given schedules and Also described guidelines for the sales, storage, display, and prescription of drugs in each schedule. List of Drug and Cosmetic Schedules: Schedule … Read more
Learn about Standard operating procedures for Camera Vision Systems and Pinhole detector including Aim, Purpose, Responsibility, Precautions, Procedure, Frequency, and Annexures. Aim: Standard operating procedure for camera vision systems in Pharmaceutical Purpose: To lay down the procedure for setting, operation, and in-process check for the camera vision system and pinhole detector. Scope: This standard operating procedure is applicable to carry out … Read more
Learn about Standard Operating Procedures on Cleaning and Sanitization in Pharmaceutical including, Aim, Scope, Responsibility, Precautions, Procedure for Different area, Frequency and Annexures. 1.0 Aim: To lay down the SOP for cleaning and sanitization of manufacturing and primary packing area. 2.0 Scope: This SOP is applicable to the entire area in the tablet department at the plant. 3.0 Responsibility officer:3.1 Production is responsible for … Read more
1.0 Purpose: The purpose of this SOP is to lay down the procedure for effective training of personnel working at a manufacturing site. In order to ensure that all employee receives appropriate training which would enhance their knowledge, experience, skill, ability, and behavior to execute their appropriate duties and responsibilities in such a manner, to provide Assurance that the … Read more
Data integrity is a key approach in the pharmaceutical quality control system. ALCOA stands for (Attributable, Legible, Contemporaneous, Original, and Accurate). It was introduced in the 1990s to ensure the framework for data integrity and good documentation practice (GDP). Then further introduced another term called ALCOA+. ALCO+ stands for (Complete, Consistent, Enduring, and Available) currently used by the … Read more
Learn about Standard Operating procedures on Solid flow Monitor Test to check the integrity of bags including Purpose, Scope, Responsibility, Procedure, and Precautions. Importance of SFM test: A solid flow monitoring test is used in pharmaceuticals to determine the integrity of the fluid bad drier bags. SFM test senses the flow of powder, and FBD … Read more
Pharmaceutical products are generally contaminated by microorganisms, cleaning agents, or other materials, But in many cases, it may be due to the repeated use of the same equipment for processing. To avoid this problem FDA introduced the Cleaning method validation process for pharmaceutical industries. The cleaning procedure must be strictly followed to execute the cleaning method. Normally … Read more
Serialization in pharmaceuticals plays a vital role in securing product information, counterfeit, and falsified medicine that puts world public health at risk. These medicines are also not only ineffective but actively dangerous, inflicting adverse reactions or even death. What is more, these counterfeit medicines are also factory-made in multiple locations, e.g., chemical synthesis in one … Read more
The Packing of drugs is a very crucial part because the safety of drugs is a must at every stage from manufacturing to packaging. Packaging helps the drugs to prevent from the external environment. Today, there are numerous job opportunities available in the pharmaceutical field, providing you with various options to shape your career in … Read more
Learn about Standard operating procedures for calibration of weighing balance, including Aim, Purpose, Scope, Responsibility, precaution, Operation, and cleaning. 1.0 Aim: The SOP for calibration of weighing balance (Trolley Balance) is applicable for all departments at the Production site.2.0 Purpose: The purpose of this sop is to calibrate of weighing the balance of the bin lifting trolley.3.0 Scope: This sop is applicable … Read more
Validation is the established document evidence or proof that provides a high degree of assurance. A particular method can systematically produce a product that meets its predetermined specifications and quality attributes. Process validation is also a component of the validation, which is explained below. Introduction to Pharmaceutical Validation: The Importance of Validation in Pharmaceutical Validation … Read more
Standard Operating Procedure for Coding and Calibration of Standard Weight, Scope, Responsibility, Precautions, Frequency, Procedure, and Yearly Calibration of Analytical Weight and Standard Weight. 1.0 Scope: The SOP is applicable for the Coding and Calibration of Standard Weight including analytical balance in the various departments at the plant. 2.0 Responsibility: 3.0 Precautions:3.1 Check the validity of the calibration … Read more
Standard Operating Procedure for Acceptable Quality Level (AQL) includes; Purpose, Scope, Responsibility, Precautions, Procedure, Classification of Defects for AQL, and AQL Charts. 1.0 Purpose: To lay down the standard procedure for an acceptable quality level for semi-finished tablets to evaluate physical attributes before packing. 2.0 Scope: This sop is applicable to all tablet products manufactured at the … Read more