Annual Product Quality Review Procedure

Annual Product Quality Review Procedure Purpose: The purpose of this Sop is to provide guidance for performing and documenting annual product reviews. and it’s also a GMP requirement to provide reliable procedures for a drug manufacturer to review the quality standards for each drug product. Annual Product Quality Review: Annual product review is an evaluation […]

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Process validation in pharmaceutical industry

In this article, we will discuss process validation in the pharmaceutical industry(Alvamax Drench).    Objective: To conduct the process validation of the manufacturing process for the Alvamax 100 Drench manufactured at the Vetlab(Pvt) Ltd(liquid section). The Validation study shall be conducted for the generation of sufficient data to establish documentary evidence and to provide assurance […]

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HVAC System Validation Reports

HVAC VALIDATION/TEST REPORT   Sr # Parameters Results 1 Area of room  (cubic ft) 2 Req CFM 3 Req. No of air changes 4 Air velocity (ft/min 5 Grill size (sq.ft 6 Required Temp 7 Req Humidity 8 Room Pressure     Particle Count: Test Apparatus /Method: particle counter: __________________________________________________ Viable monitoring: Test Apparatus /Method: […]

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clean steam

Clean Steam Validation

In this article, we will discuss the Clean Steam Validation procedure using in pharmaceutical sterile manufacturing. A sampling of Pure steam for Bacterial Endotoxin Testing & Viable Count Samples for Bacterial endotoxin evaluation should be collected in dehydrogenated tubes/bottles. Remove the cap from the bottle immediately prior to obtaining a sample. While samplings avoid direct […]

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Analytical Method validation of Drench

1.0 Method Validation: Analytical method validation is the process to confirm that the analytical procedure employed for a specific test is suitable for its intended use. 2.0 Objective: Analytical monitoring of a pharmaceutical product is necessary to ensure its efficacy throughout all phases of its shelf life; such monitoring is in accordance with the specifications […]

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Qualification of Semi automatic Injection filling machine

In this article, we will discuss the Qualification of Semi-automatic Injection filling machine IQ OQ PQ Overview Brief: Correct functionality and performance of equipment to obtain reliable and accurate data therefore equipment qualification should be part of any good manufacturing practice. The contents of the qualification workbook are as follows.   Installation Qualification (IQ) for […]

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Clean Room Environmental Control

1   PURPOSE To ensure control over viable and non-viable count in the clean area. 2     SCOPE This procedure is applicable for a different part of all manufacturing areas of the sterile dosage form. (Injection section) 3     RESPONSIBILITY Microbiologist, Quality Control Manager, Section Supervisor, Production manager 4     Equipment/APPARATUS i) Nutrient Agar ii) Tryptone […]

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