Procedure for Planned Internal Quality Audits in Pharma

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Procedure for Planned Internal Quality Audits in Pharma

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

Difference Between Validation, Calibration, and Qualification in Pharma

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Difference Between Validation, Calibration, and Qualification

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

SOP on Storage and Movement of unlubricated granules / Transfer

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SOP on Movement of unlubricated

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

SOP on Storage and labeling of Raw and Packing Materials

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SOP on Storage and labeling of Raw and Packing Materials

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

SOP on Rapid Mixture Granulator cleaning and procedure

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SOP for Rapid Mixture Granulator cleaning and procedure

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

SOP on Vibro Sifter operation and Cleaning

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Vibro Sifter SOP

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 measurement and operation in Pharma

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vernier caliper

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

Technical Pharmaceutical Interview Questions/Answers

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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

SOP on Collection of Swab and Rinse Water Samples

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SOP on Collection of Swab and Rinse Water Samples

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 Corrective and Preventive Action in Pharmaceutical

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fishbone structure, CAPA IN PHARMACEUTICAL

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

Handling of Laboratory Incident in Pharma

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laboratory incident

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

Aseptic and Sterile in Pharmaceutical

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aseptic and sterile

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

SOP for Cleaning of Quality control department

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SOP for Cleaning of Quality control department

Learn About Standard Operating Procedure in Cleaning of Quality control department including Their, Aim, Purpose, Responsibilities, Procedure to clean the Floor, Wall, Door, Window, Glass, Ceiling, Air Grill, Waste Bin, Working Bench, Light Fixture, and Drain Point. 1.0 Aim: To lay down the standard operating procedures for cleaning the Quality Control Department in Pharmaceutical. 2.0 Responsibility:2.1 Housekeeping Personnel: … Read more

Calibration of UV-visible spectrophotometer

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calibration UV-visible spectrophotometer

UV-visible spectrophotometer are widely used in the pharmaceutical industry for analyzing and quantifying various drug substances. It is important to ensure that these instruments are calibrated accurately and regularly to obtain reliable and accurate results. In this guide, we will take you through the calibration procedure and parameters of a UV spectrophotometer. Calibration of UV-visible … Read more

isopropyl Alcohol 70 percentage Preparation SOP

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Isopropyl alcohol

Learn About Standard Operating Procedure on IPA 70 % Preparation including their, Purpose, Scope, Procedure, frequency, and Annexures. 1.0 Purpose: To lay down the Standard Operating Procedure for the Preparation of 70 percent v/v Isopropyl Alcohol Solution. 2.0 Scope: This SOP applies to the preparation of 70 percent v/v Isopropyl Alcohol Solution. 3.0 Procedure: 3.1 Requisition for Isopropyl … Read more

Understanding Sterility Assurance Level (SAL) vs. Log Reduction in Pharmaceuticals

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https://pharmaguddu.com/sterile-assurance-level-sal-vs-log-reduction/

Sterilization processes are critical in the pharmaceutical industry for ensuring the safety and efficacy of medical products. To calculate these Pharmaceutical professionals use two terms, Sterility Assurance Level (SAL) and Log Reduction. Understanding these concepts is key to microbial control, quality assurance, and regulatory compliance. In this post, we explore these terms, their calculations, and … Read more