HVAC

HVAC Cleaning and maintenance SOP

1. Purpose To provide cleaning instruction of HVAC & various types of filters in AHU as per safety and cGMP requirements 2. Scope This SOP covers the instructions for cleaning of pre-filters and fine filters of all AHU. 3. Responsibility HVAC Operator Maintenace Incharge Production manager Quality assurance officer 4. Cleaning Procedure OF HVAC UNIT Ensure […]

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Calibration Of Instruments

If your query is Calibration Of Instruments at the pharmaceutical plant, please follow this sop 1. Purpose This procedure describes conditions pertaining to an adequate and organized calibration system of measuring devices. 2. Scope This SOP is applicable for the Calibration Of Instruments at the Pharmaceutical plant 3. Responsibility QA Officer QC analyst Production Manager […]

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apqr

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

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 REPORTS

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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AMV

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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Qualification of Laboratory Equipment’s

IQ OQ PQ Overview Brief: Correct functionality and performance of scientific apparatus to obtain reliable and accurate analytical data therefore instrument qualification should be a part of any good analytical practice The contents of the qualification workbook are as follows. Installation Qualification (IQ) for performing and documenting the installation in a location selected by the […]

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