GOOD MANUFACTURING PRACTICES
Here comes my blog on the topic GOOD MANUFACTURING PRACTICES.
REASON BEHIND THIS BLOG
Whenever I go through websites that provide information on jobs and openings, I see companies asking for proper knowledge on GMP. So that's the main reason that made me present this blog.
GMP takes care of both production and quality control. Simply speaking,it makes sure that the products are produced constantly on the same principle and these products are reaching the quality standards which the marketing authorization need or the purpose for which the product is produced. GMP is included under quality assurance and it includes quality control. (1)
These guidelines are the minimum guidelines that the company has to follow or else the product will be considered adulterated.(2) It not only makes sure that the product is attaining the same quality at the end, but it also makes sure that the product is produced by the same method every time. (3)
The credit for the introduction of the GMP will go to the USFDA. (2)
So let us see who will enforce GMP on industries in some individual countries. (2)
Ministry of Health
National Regulatory Agencies
Therapeutical Goods Administration
The GMP needs (1)
-The process of manufacturing a product should be described properly and this must be done in the presence of well experienced persons and this process must make sure that the products of desired standards are obtained.
-Good well trained personnel, good equipment, premises, good containers, labels and storage conditions must be properly supplied.
-Proper training must be given,so that the personnel will do the operations precisely.
-During the operation, records are to be prepared,which make sure that all the steps are proceeding as defined and the required quality and quantity are achieved.In case of any variation, it is recorded and the reason is identified and corrected.
-The distribution of the product should be such that it causes minimum risk of contamination.
-Once the product is sent to the market, there doesn't end the matter but proper system should be there to recall the product if required.
-Feedback must be taken. If there are any complaints, then the reasons must be identified and proper measures are taken so that they will not happen in the future.
So how can we achieve GMP:
Just follow these rules. (4)
Friends... if we follow these rules we can achieve GMP.
- FACILITY DESIGN: In the pharmaceutical industry the layout should be designed in such a way that, there will be least risk for any cross contamination?
The products should move in a linear direction.
There should be adequate lighting in the industry and proper care is taken in order to maintain the humidity and temperatures according to the requirements.
The walls should be smooth and there should be no cracks on the walls and they should be easy to clean.
Equipment should be placed at the correct position where it is easy to handle and clean. Equipment maintenance should be easy and should be calibrated whenever required.
- VALIDATION: Friends... what is the guarantee that the process and equipment is functioning according to the predetermined manner? The guarantee is validation. It is a document which guarantees that the process and equipment are giving the products which meet the predetermined specifications.
Installation qualification, operational qualification and performance qualification are involved in the validation part.
- PROPER PROCEDURES: Preparing the proper procedures is very important for GMP. We write records in labs. Some will write sincerely and others will write for external (including me). while writing the record, we write the aim and then procedure followed by tables etc. even in industry the procedures are written with aim and the procedure should be concise and clear. None will study the documents from first line to last line, but they will search for important points. Flow charts help to have a quick review through the crucial steps and important points.
These are the important questions while using the personnel. Which person has to do which work should be clearly specified and each person should be well aware of what he has to do. Training should be given. Enough number of individuals must be recruited.
-RECORDS: In industry Good records should be maintained, about what we have done from the raw material stage to the end product stage.
While writing our records, if we write a mistake we will scratch it so that sir shouldn't understand what mistake we did and while writing the observations, sometimes we will not write the readings immediately rather we will depend on our memory. But these are not encouraged in industry. Once the process has been completed in preparing a batch, then the required details are noted. If there are any mistakes,one straight line should be drawn on it.
-SANITATION: Maintaining the proper sanitation is very important in order to avoid contamination.
people working in the industry should clean their hands properly and Prevent eating and drinking.
If they are not feeling well, they should not be allowed to enter into the manufacturing area.
proper sanitary conditions must be followed and proper disposal of the trash must be done.
-EQUIPMENT MAINTAINANCE: I have one close sir by name Varma (sir) in my 7th class. He got a bajaj caliber during those days and still he is using the same bike now which is in super condition. He cleans it very often and uses it properly. And now in B.Pharmacy I see my friends getting pulsars and within 6months, the bikes are out of condition. It's a risk to travel on their bikes because no one can guess when the brakes will malfunction.
So the same thing is done in the industry. The equipment should be properly maintained. If once it breaksdown, then you have to spend more for repair and the product will get contaminated. Proper cleaning and maintenance of equipment is required.
The last date when the equipment was used, the purpose for which it is used, last time when it is cleaned, repaired and calibrated are properly documented.
-The raw materials must be properly tested. Rejected materials should be properly stored so that we will not use them unknowingly. Make sure that the same person is doing the same function every time. Proper packaging and labeling must be done. It is the area where there are lot of chances for any sort of mix-up. There should be different places for testing the quarantine and finished products.
Here I want to conclude that GMP is very important in the industry and students have to start learning it from the college labs itself.
1.Good pharmaceutical manufacturing practice rationale and compliance by John Sharp, CRC press, 2004, page no 11 and 12.
2.http://www.csas.ed.ac.uk/__data/assets/pdf_file/0011/38828/GMPinPharmaIndustry.pdf(accessed on 20th September 2011 11:00PM)
3. http://whqlibdoc.who.int/hq/1997/WHO_VSQ_97.02.pdf (accessed on 21stSeptember 2011 10:00PM)
4. http://www.pharmout.net/downloads/white_paper_10_golden_rules.pdf (accessed on 25st September 2011 11.00 PM)
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