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
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
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
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
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
Before discussing how to face an interview confidently, you first need to understand what interviews entail. Interviews are defined as a “meeting of persons face to face, especially for purposes of consultation; oral examination of a candidate for employment, etc.” An interview has now become a crucial criterion for selecting individuals at all levels – … Read more
Learn About the Standard Operating Procedures of Tipper including their, Purpose, Scope, Responsibility, Operation, Cleaning, and Precautions. 1.0 Purpose: To provide the SOP on tipper operation and cleaning. 2.0 Scope: This SOP is applicable for the operation and cleaning of the tipper in the production department at the Plant. 3.0 Responsibility: 3.1 Production Operator:3.1.1 To perform the operation and … Read more
The Standard Operating Procedure (SOP) for the in-process Quality check is applicable to all areas in the production line and packing line at different stages, as described in this SOP. In-process Quality checks are crucial for maintaining product quality and safety at every stage. Purpose: SOP for carrying out in-process Quality checks during the manufacturing and … Read more
Learn About Standard Operating Procedure on Storage and Hold time Study for Products along with their Purpose, Scope, Responsibility, Definition, Procedure, Selection of Test parameters, Sampling Interval/volume, and container, Hold time study at different stages, and Documentation. 1.0 Purpose: 1.1 To lay down Standard Operating Procedure for Storage and Hold Time of Starting Material, Intermediate, and Bulk Products. … Read more
The following ICH (Q1A, R2, and Q1B step 5) and FDA guidance explain the accelerated stability testing and their studies. It is important to conduct stability studies to guarantee good quality, safety, and efficacy of drugs throughout their lifecycle which must be satisfied before any pharmaceutical product can be accepted or approved. These accelerated stability … Read more
Learn About Standard Operating Procedures for Daily Verification of Weighing balance along with their, Purpose, Scope, Responsibility, Precautions, Procedure, Operation, and Tolerance limit. 1.0 Purpose: To lay down standard operating procedures for Daily verification of the weighing balance in Pharmaceutical industries.2.0 Scope: This Daily Verification of Weighing balance is applicable for all the weighing balances used in … Read more
By definition, Weighing balance calibration is a process of verifying the accuracy and precision of a weighing balance used in pharmaceutical manufacturing. It involves comparing the measurement of the balance to a known standard to ensure that it is providing accurate results. In the pharmaceutical industry, we perform monthly calibration on weighing balances to verify … Read more
Learn about the Standard Operating Procedures for the induction cap sealer machine, including their scope, responsibilities, precautions, procedures, and operation. 1.0 Scope: This SOP is applicable to setting and operating an induction cap sealer machine in the tablet department. 2.0 Responsibility: 2.1 Officer production is responsible for the implementation of this SOP2.2 Head production is responsible for ensuring the … Read more