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
In pharmaceutical manufacturing, following entry and exit procedures for staff and visitors is essential to prevent external environmental dust and microorganisms from entering the cleaned area. These procedures also help prevent contamination and cross-contamination within the manufacturing facility. According to WHO pharmaceutical guidelines, a well-defined procedure for on-premises entry and exit must be in place. … Read more
Pharmaceutical Sampling involves selecting a portion of a product for a specific purpose. The sample is a part of a material collected following a defined sampling procedure. A Sampling plan specifies the location, the number of units, the quantity of material to collect, and the associated acceptance criteria. The Sampling procedure contains all sampling operations … Read more
A capsule is a type of Unit dosage form in the pharmaceutical industry. It consists of small, cylindrical components made of either soft or hard gelatin, filled with a powder or liquid. Capsules are taken orally and are designed to release their contents after swallowing. They are commonly used for medications intended to be absorbed … Read more
Learn About Standard operating procedures for the Destruction of Microbial waste by Autoclaving methods along with their Objective, Scope, Responsibility, and procedure. 1.0 Objective: 1.1 To lay down the procedure of the Destruction of microbial waste by autoclaving.2.0 Scope: 2.1 This SOP applies to carry out the procedure of Destruction of microbial wastes by autoclaving in a microbiology laboratory 3.0 Responsibility: 3.1 … Read more
Contamination and cross-contamination are terminologies used in the pharmaceutical industry when products undesirably come into contact with or mix with other products or their parts. Contamination can occur in starting materials or products due to contact with other related products. The risk of accidental contamination may arise from the uncontrolled release of dust, gases, particles, … Read more
MACO and NOEL calculations have great importance in the pharmaceutical industries. NOEL refers to “No observed effect level” and MACO is a “Maximum allowable carryover”. NOEL is used to determine MACO during cleaning validation. NOEL Calculation: NEOL is calculated by using LD50 and average. Adult dose. LD50 is a lethal dose (it may vary), considered an adult’s … Read more
Pass boxes are cleanroom systems used to transfer materials from one area to another cleaned area through a controlled environment. Pass boxes help control contamination and cross-contamination by passing particular matter present on the surface of materials that are to be transferred. These materials automatically pass through the filter present on the pass box during … Read more
Documentation forms the base of any company’s Quality Management System and serves as an essential GMP requirement. Anyone handling GMP documents and documentation systems must understand the regulatory requirements. Requirement of Good Documentation Practice? Good Documentation Practice is essential for proof of invention, company operations, technology transfer, regulatory requirements, and liability protections. The Documentation System … Read more
GxP in pharmaceuticals is a set of Good Practices; it ensures the quality and effectiveness of products for drugs, food, medical equipment, and other life-serving products as per regulatory standards. Meaning of GxP in Pharmaceuticals: GxP is part of Good practice because it’s related to the manufacturing of life-saving products. GxP helped in controlling the … Read more
Learn About Standard Operating Procedure for Sterile failure investigation within sterile testing Areas including their, Aim, Scope, Responsibility, Procedure, and Definitions. 1.0 AIM: To lay down the cleaning procedure for the Sterility failure investigation.2.0 SCOPE: This SOP applies to carry out the cleaning procedure for the Sterility failure investigation.3.0 RESPONSIBILITY: Executive – Provide training for Cleaning procedure for the Sterility testing area … Read more
Learn About Standard operating procedure on Laminar airflow in a Micro laboratory including their, Aim, Scope, Responsibility, distribution, Procedure, and Annexures. 1.0 AIM: To lay down the procedure of Operation of Laminar airflow in the microbiology laboratory.2.0 SCOPE: This SOP applies to carry out the procedure Operation of Laminar airflow in the microbiology laboratory at a pharmaceutical plant. 3.0 RESPONSIBILITY:3.1 Executive … Read more
Learn About Standard Operating Procedure for Microbial Incubator operation and their Calibration along with Objective, Scope, Responsibility, Procedure, Frequency, and Tolerance Limits 1.0 Objective: To get reliable and consistent results, we must ensure the procedure and maintenance of the Microbial Incubator, especially for temperature maintenance for Microbial growth. 2.0 Scope: This procedure is applicable to … Read more
Discover the effective process for conducting planned internal quality audits within the pharmaceutical industry. Learn how to optimize quality assurance practices while ensuring compliance with regulatory standards. Gain insights into enhancing pharmaceutical audit procedures and achieving operational excellence. 1.0 PURPOSE: 1.1 The purpose of this procedure is to implement a system for planned internal quality audits … Read more
There is often confusion surrounding the terms validation, calibration, and qualification within the pharmaceutical industry. Let’s explore their differences with explanatory examples. Difference among Validation, Calibration, and Qualification 1. Qualification: Qualification is the process of planning, conducting, and documenting test results performed on equipment to confirm its operational capability. It demonstrates that the equipment will … Read more
Learn about Standard Operating procedures for Storage and Movement of unlubricated granules / Transfer including their Purpose, Scope, procedure for Storage of Unlubricated / Graded Granules, transfer of Unlubricated Granules to Blender Room, Precautions, and Annexures. 1.0 Purpose: 1.1 To lay down the Standard Operating Procedure for storage and movement of unlubricated granules and their transfer to … Read more