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Pharmaceutical Guidelines


Sep 25, 2016

Temperature and Humidity Validation/Mapping in Storage Area


Temperature and humidity are important factors in the stability of the pharmaceutical ingredients. Temperature sensitive materials can degrade at higher temperature therefore it important to validate the storage area for temperature.

Sep 18, 2016

Handling Static Charge in Pharmaceutical Manufacturing


Static charge is the electric current developed by the rubbing of moving parts of equipments or contact and separation of material particles. It is generated in different pharmaceutical manufacturing equipments during processing. Sometimes it is generated by the continuous flow of the powder on the equipment surface.
Sep 11, 2016

Major Audit Findings about Equipment and Instruments


1. Deviations through the equipment and instruments are not documented and investigated such as any equipment is not cleaned as per the defined procedure; calibration procedure is not followed properly etc.
Sep 4, 2016

Importance of Qualified Persons in Pharmaceuticals


Qualified and trained employees are the keys to manufacture the good quality product. Every step of pharmaceutical manufacturing and analysis should be done by the competent person. All regulatory agencies have their guidelines for qualified persons and their training.
Aug 28, 2016

Importance of Blend Uniformity in Manufacturing Process


Blend uniformity is an important factor in pharmaceutical manufacturing. A poor uniformity of the blend can cause the rejection of the product that can lead to the loss of revenue.
Aug 21, 2016

Why Firms Must Avoid FDA 483 and Warning Letters?


FDA has the mandate of ensuring the safety of the public by assuring the safety of drugs and medical devices among others. To this end, FDA officials occasionally visit manufacturing establishments for the purpose of carrying out an inspection to find out whether or not the establishment is in compliance. After an inspection, FDA officials may issue FDA 483 and warning letters. Sometimes, the manufacturer may receive an FDA 483 form without a warning letter.

Aug 14, 2016

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing


Both of these techniques are used to manufacture sterile pharmaceutical products as parenteral (LVP & SVP), infusions, ophthalmic and inhalation products. These are automated techniques to prepare sterile products.
Aug 7, 2016

Requirements for Good Documentation Practice (GDP)


Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.
Jul 31, 2016

Acceptable Quality Level (AQL) in Pharmaceuticals


Acceptable Quality Level is a sampling plan according to the batch size and inspection levels. Some buyers have this requirement to follow the AQL therefore some manufacturing units have started following this concept in pharmaceuticals.
Jul 24, 2016

Procedure for Sampling in Process Validation


Sampling plays a major role in achieving the accurate results of analysis. Sampling plan and procedure must be defined in validation protocols and training should be provided to the concerned staff before the validation activity starts.
Jul 17, 2016

Preparation of MFR for Pharmaceuticals


Master formula record (MFR) is a master document for any pharmaceutical product. It contains all information about the manufacturing process for the product. MFR is prepared by the research and development team of the company and all other documents like BMR and BPR are prepared using MFR by the manufacturing units.

Jul 10, 2016

Human Generated Contamination in Cleanroom and its Control


Cleanroom contamination is a major problem in sterile manufacturing and it is difficult to maintain the cleanroom area. People working area are the major source of contamination.
Jul 3, 2016

Is It Possible to Switch off HVAC System in Night?


Maintenance of clean room area is very expensive. It is a common question that everyone wants to ask that can we switch off our HVAC systems in night or at the time when area is not in use to save the power consumption?
Jun 26, 2016

Tips to Develop Equipment Cleaning Procedure


A well developed cleaning method is a primary requirement of the cleaning validation. Cleaning procedure should be developed before starting the cleaning validation. Following things should be considered during development of good cleaning procedure.
Jun 19, 2016

Lux and Light Intensity for Pharmaceutical Areas


Sufficient light is necessary at work place to get better work output. Less lighting in working area can result errors in different ways. None should experience eye-strain during his work.
Jun 12, 2016

4 Tips to Reduce 483 Observations


483 is a FDA form that is issued to report the GMP inspection observation by FDA officials. It contains all objectionable activities found by the FDA inspector during the inspection of a manufacturing facility.