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
Learn About Standard Operating Procedures for Storage and labeling of Raw and Packing materials including their, Purpose, Scope, Responsibility, Procedure, Precautions, and Records. 1.0 Purpose: 1.1 The purpose of this SOP is to implement system storage and labeling of Raw and Packing materials in raw material stores.2.0 Scope: 2.1 This SOP is applicable to all raw materials; packaging … Read more
Learn about the Standard Operating procedure on RMG including their, Purpose, Scope, Responsibility, Checkpoints, procedure, cleaning, discharging, and Frequency. 1.0 Purpose: To lay down SOP on Rapid Mixture Granulator for Operation and Cleaning.2.0 Scope: This SOP applies to RMG operation and cleaning In pharmaceuticals.3.0 Responsibility: 3.1 Operator, Officer Production is responsible for the implementation of this SOP.3.2 Head Production is responsible for ensuring compliance with this SOP … Read more
A vibro sifter is used in pharmaceuticals to crush the solid mass of granules and create the desired size of granules using sieves. Let’s understand the cleaning and operation procedures of the vibro sifter. 1.0 Objective: 1.1 To lay down the procedure for Vibro Sifter operation and Cleaning2.0 Aim: This procedure is applied to Vibro … Read more
Vernier caliper is used widely in pharmaceutical and other industries for Accurate Measurement of any products and part of the equipment is essential to know the actual dimension. So to measure the dimension first you have to know about, the vernier caliper Definition, procedure, parts, operation, cleaning, error solutions, and purpose. Vernier Caliper Definition: The Dial … Read more
Providing brief and accurate answers to interview questions is crucial for success in the selection process. While it can be challenging to find answers to certain questions, it is important to familiarize yourself with pharmaceutical interview questions and their corresponding answers, tailored to the position level, before the interview. Pharmaceutical Interview Questions and Answers for … Read more
Learn about the Standard Operating Procedure for the Collection of Swab and Rinse Water Samples, including their purpose, scope, responsibility, procedure for Swab Sampling, Sampling frame, Rinse Water Sampling, and Annexures. 1.0 Purpose: 1.1 To lay down the Standard Operating Procedure for the collection of the swab and rinse water samples2.0 Scope: 2.1 This SOP is applicable to all the … Read more
CAPA stands for Corrective Action and Preventive Action. It is a tool used in quality management systems in the pharmaceutical industry. The purpose of corrective and preventive action is to analyze, identify problems, and implement appropriate measures to prevent their recurrence. CAPA meanings/ Definition Corrective action is the action taken to eliminate the causes of … Read more
Laboratory Incident Definition: Any unintentional or unexpected event occurring during, discovered within, or arising after analysis that may adversely impact the quality of data and the resulting outcomes. Types of Common Laboratory Incidents: Below are the different common types of lab incidents in the pharmaceutical field that often occur. Type of Lab incident: Laboratory incidents … Read more
Terms aseptic and sterile are significant concerns, and sometimes it is not easy to understand the differences between the two terms. For example, in the case of environment classification, some people might say the “sterile area”, and others use the term “Aseptic area”. USP General information chapter no. 1116 describes the terms Aseptic and Sterile … Read more