The Restricted Access Barrier System (RABS) enhances product control but reduces operator communication in aseptic manufacturing. The main aim of the RABS in pharmaceutical products is to ensure they are free of all contamination risks. During the early 1990s, new systems were developed to help sterile pharmaceutical manufacturers ensure contamination-free sterile products at a very … Read more
Learn About SOP on Hardness Tester | SOP Operation, cleaning, and Calibration of Hardness Tester in Pharmaceuticals. 1.0 Purpose: To lay down the Standard operating procedure for cleaning and operation of tablet Hardness Tester. 2.0 Scope: This SOP is an applicable tablet hardness tester in the pharmaceutical department. 3.0 Responsibility: 3.1 The QC/QA Officer is responsible for the implementation … Read more
Injectable preparations, also known as parenteral preparations, are sterile formulations used for parenteral infusion or implantation. They are administered by injection to maintain sterility and prevent contamination by foreign matter, pyrogens, microorganisms, and bacterial endotoxins. These preparations must be made using methods that ensure sterility. Water for injection (WFI) is commonly used as a vehicle … Read more
Learn About the Standard Operating Procedure for Cleaning and Sanitization of the Microbiological Department along with their, Objective, Scope, Responsibilities, and How to clean and sanitize the Micro Department. 1.0 Objective: SOP On Cleaning Procedure Microbiology department, the department must be clean and sanitized according to the prescribed procedure. 2.0 Scope: This standard operating procedure applies to … Read more
Tablet excipients generally have no medicinal properties, although excipients are used to fill the drug’s bulk mass. Excipients also facilitate sustaining the drugs for a long time and help increase bioavailability in systemic absorption. Excipients might help in disintegration, lubrication, masking the test, and tablet hardness. The different types of Tablet excipients are explained below with … Read more
1.0 Purpose: 1.0 To lay down the Standard Operating Procedure for using the Door Interlock System. 2.0 Scope: 2.1 This SOP applies to all Personnel, including Visitors Entering or Leaving the Man / Material Entries that have Door Interlock System. 3.0 Responsibility: 3.1 All Personnel entering or Leaving the Man /Material Entries having Interlocking Systems are responsible for adhering to the procedure.3.2 Head … Read more
The Friability test helps measure the powder lost from tablet surfaces during handling and transport. This test is typically done on uncoated tablets. The parallel to friability test, tablets hardness, is also tested to know the strength of tablets which is more important for drugs to withstand throw-out their lifecycle. However, hardness is not only a parameter … Read more
Inside this standard operating procedure, you will learn about the Disposal of Microbial Media culture waste and the Maintenance of Slants / Butt and Culture. 1.0 Objective: To lay down the procedure for the Maintenance and disposal of Microbial media in the Microbiology Laboratory. 2.0 Scope: This Standard Operating procedure for the Maintenance and disposal of Microbial … Read more
The world is evolving rapidly, with new diseases and disorders emerging, leading to a higher demand for novel discoveries, including new drug findings. There is consistently high demand for aligning medicinal products to uphold and ensure quality, safety, and efficacy standards for each product. The ICH Guidelines for pharmaceuticals play a significant role in ensuring … Read more
Quality assurance plays an essential role in manufacturing high-quality pharmaceutical products. It is the aspiration of many to secure positions within the quality department. To achieve this goal, individuals must be successfully guided to excel in interviews. To aid in this industry, we have curated a list of 100+ Quality Assurance Interview Questions suitable for … Read more
In this Standard Operating Procedure (SOP), we will discuss the proper procedures for cleaning and monitoring an aseptic area including; their Objective, Scope, Responsibility, Cleaning, and monitoring by Setting Plate Tests. 1.0 Objective: This SOP gives guidelines for cleaning and monitoring of aseptic area in the injection section of the production department 2.0 Scope: This SOP on Cleaning … Read more
Read about the Standard Operating procedure on DHS along with precautions, and DHS setting for Aspectic and Non-Aseptic areas. 1.0 Objective: To lay down a procedure for operation Dry Heat Sterilization (DHS) in the injection section. 2.0 Scope: This SOP on Dry Heat Sterilization is applicable to the Injection Section of the production department at the plant. 3.0 Responsibilities:Officer- Production for implementation … Read more
Handling Scrap And Disposal coming from any regular production run assumes great significance in the pharmaceutical industry. Improper destruction procedures followed can lead to a problematic situation if such material finds its way into the wrong hands. 1) Objective: To lay down instructions for the management of Scrap generated in different departments of the Organisation to ensure … Read more
Learn about the Standard operating procedure on the vials washing machine in pharmaceuticals along with their Objective, Scope, Responsibility, procedure, precautions, cleaning, and acceptance criteria. 1.0 Objective: To lay down a procedure for Cleaning and operation of vials washing machine to make vials free from particulate matter.2.0 Scope: This SOP applies to the Injection Section of the production department. … Read more
Learn about the Standard procedure for the Sterilized Powder filling machine in the injection section along with their Objective, Scope, Responsibility, Procedure, and cleaning process. 1.0 Objective: To lay down the procedure for efficient Cleaning & Operation of the Sterilized Powder filling machine. 2.0 Scope: This SOP for Cleaning & Operation of a Sterilized Powder filling … Read more
Learn About Standard Operating procedure on the Depyrogenation method and washing of Test tubes for BET. 1.0 Object: 1.1 To lay down the procedure for the Depyrogenation method and washing of test tubes for BET. 2.0 Scop: 2.1 This SOP applies to carry out the procedure of the Depyrogenation method and washing of test tubes for BET in a microbiology laboratory … Read more