SOP Operating of Vials Labeling Machine

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SOP Operating of Vials Labeling Machine

Learn About Step by Steps Standard Operating Procedures for Vials Labeling Machines along with their Objective, Scope, Precaution, and Procedure. 1.0 OBJECTIVE: To lay down the procedure for operating of vials labeling machine.2.0 SCOPE: This SOP is applicable in the Department of Production for the Injection Section. 3.0 RESPONSIBILITIES:Head – Production for overall compliance with this SOPOfficer- Production for implementation tp … Read more

SOP Operation and Cleaning BOD Incubator in Microbiology Department

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SOP Operation and Cleaning BOD Incubator in Microbiology Department

Learn about Standard Operating Procedure Operation and Cleaning BOD Incubator in the Microbiology Department along with their Objective, Scope, Responsibility, procedure, Calibration, and Frequency. 1.0 Objective: To achieve reliable and consistent results, we must ensure that we operate, calibrate, maintain, and clean the BOD (Biological Oxygen Demand) Incubator, especially focusing on temperature maintenance for total … Read more

SOP on cleaning And Operation of Static Pass Box

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Static pass box

Learn About the Standard Operating procedure for Static Pass Box in Pharmaceuticals along with their Purpose, Scope, Responsibility, Operation, and Cleaning. 1.0 Purpose: To lay down the standard operating procedure for cleaning and Operating of static pass box. 2.0 Scope: This standard operating procedure is applicable for the cleaning and Operation of static pass boxes in the … Read more

Restricted Access Barrier System (RABS) in Pharmaceutical

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Restricted Access Barrier System

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

SOP on Cleaning Operation Tablet Hardness Tester

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SOP on Cleaning Operation Tablet Hardness Tester

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 | Parenteral | Sterile Preparations, types, Standard test

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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

SOP on Cleaning / Sanitization Microbiology Department

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SOP on Cleaning / Sanitization Microbiology Department

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 used In Pharmaceutical Manufacturing

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binder-and-adhesive- tablet-excipients

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

Standard Operating Procedure for Door Interlock System

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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

Tablet Friability Test Calibration and Specification

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Friability test apparatus specification

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

SOP on Disposal of Microbial Media in Microbiology

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Disposal of Microbial Media in Microbiology

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

ICH Guidelines in Pharmaceutical (updated)

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ICH Guidelines in Pharmaceutical

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

100+ Quality Assurance Interview Questions Pharma

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Quality Assurance Interview Questions Pharma

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

Sop on Cleaning and Monitoring Aseptic area

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Sop on Cleaning and Monitoring Aseptic area

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

SOP for Dry Heat Sterilization in injection section

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SOP for Dry Heat Sterilization in injection section

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

SOP on Handling Scrap and Disposal in Pharmaceutical

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SOP on Handling Scrap and Disposal in Pharmaceutical

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