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

Top Tips for face interview successfully

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To face interview

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

SOP on Tipper operation and cleaning

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SOP on Tipper

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

In Process Quality check during Manufacturing

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In Process Quality check during Manufacturing

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

SOP on Storage and Hold Time Study for Products

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SOP on Storage and Hold time study for Products

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

Accelerated stability testing (study) Important Questions

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Accelerated stability testing (study) Important Questions

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

Daily Verification of Weighing balance SOP

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Daily Verification of Weighing balance

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

Weighing Balance Calibration in Pharmaceutical

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Calibration of weighing balance

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

Induction Cap Sealer machine SOP

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Induction Cap Sealer machine SOP

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

Factory Acceptance Test (FAT) in Pharmaceutical

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Factory acceptance test (FAT)

After completing the Design Specification and Design Qualification for new equipment, a user inspection is typically conducted before the delivery to the site. This inspection is referred to as the Factory Acceptance Test (FAT). The manufacturer of a machine will prepare the FAT protocol based on the Design Qualification, as per the built machine specification, … Read more

Design Qualification in Pharmaceutical industry

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Design Qualification

A Design Qualification comes to the role after the Design Specification as well as User requirements specification are finalized. Once URS is finalized follow the given specification requirement in the purchase order (PO). After checking it properly, the engineering, and production department will prepare the design qualification, which includes drawing, calculation, symbols, and other design … Read more

User Requirement Specification (URS) in Pharmaceutical

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user requirement specification

User requirement specification (URS) is a list of all the equipment-related requirements from the user, The list shall be prepared based on the types of equipment to be purchased. After the preparation of the list, the URS documents are sent to the manufacturer to get the required materials as per the given criteria. The user department … Read more

Lux or Light intensity standards in Pharma industry

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lux or Light intensity

In the pharmaceutical industry, it’s essential to have sufficient lux or light intensity for carrying out work accurately. If the work area lacks proper illumination, it can lead to issues such as eye strain and fatigue, especially during detailed work. Excessive lighting is also unnecessary, as it may result in glare and dazzle. According to … Read more