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How Expiry dates are determined for Medicines
The expiry date printed on your medicines isn’t arbitrary—it’s carefully determined through rigorous stability studies to ensure the drug remains safe and effective throughout its shelf life. Here’s a breakdown of how it’s done: ---Step 1: Stability Studies Pharmaceutical companies test drugs under controlled conditions to monitor:Potency: The active ingredient should remain within 90–110% of … Continue reading How Expiry dates are determined for Medicines
Types of Airlocks in Pharmaceutical industry
Purpose of Air lock: The main purpose of the airlock system is to prevent cross-contamination. To prevent the entry of contaminants from less classified area to a highly classified area. In a sterile area prevent the entry of less clean air to high clean area. In a sterile area prevent the entry of microbes from … Continue reading Types of Airlocks in Pharmaceutical industry
PH Meter Principle
pH meter is a scientific instrument used to measure the pH (acidity or basicity) of a solution. Here are some key aspects of pH meters: *Components: *1. *Probe:* A glass or plastic electrode that senses the pH of the solution. 2. *Reference electrode:* A second electrode that provides a stable reference point. 3. *Meter:* The … Continue reading PH Meter Principle
Air changes per hour (ACPH)
Air changes per hour (ACPH) Ref. Guideline: ISO 14644 Air changes in pharmaceutical cleanrooms play a significant role in maintaining the clean room quality as per ISO Clean Room Classification through the HVAC system. Air change per hour is the number of total replacements of any room air in one hour. if the supply of … Continue reading Air changes per hour (ACPH)
Calibration
what is Calibration ? This refers to the process where you can determine if an instrument or device is producing accurate results within the specified limits when it is compared to traceable standards of measurement. This is important for justifying the processes of Qualification and Validation.The instrument or equipment with the known accuracy is known … Continue reading Calibration
Qualification File Requirements for New Machines in Pharma as per WHO/EU/USFDA
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SOP of SOP in Pharmaceutical Industry (How to Prepare SOP)
1.Objective To lay down procedure for preparation, review, approval, issuance & retrieval of Standard Operating Procedure. (SOP) 2.Scope This procedure is applicable to preparation of SOP for all the cGMP activities. 3.Responsibilities User Dept. QA Dept. 4.Procedure: The procedure is described further into sub parts. i.e. Preparation, Review , Approval, Distribution, Retrieval, & retention. Structurally … Continue reading SOP of SOP in Pharmaceutical Industry (How to Prepare SOP)
Deviation Flow Chart
Difference between Dynamic and Static Pass box
In pharmaceutical manufacturing industries, pass boxes are normally used to transfer a particular material between two areas generally of different cleanliness levels. The boxes can be said to transfer the materials from a high level of cleanliness to a lower level of cleanliness or vice-versa. The pass boxes while transferring the material, help to prevent … Continue reading Difference between Dynamic and Static Pass box
Pharmaceutical Updates 