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Thursday, June 16, 2011

Good manufacturing practices GMP guidelines pharma industry

Good Manufacturing Practices guidelines its importance in (gmp guidelines) For Pharmaceutical Industry.

A drug, medical device can be treated as adultrated even if they pass or comply all the final specifications and are found to be manufactured where in a condition where current good manufacturing practices are not followed properly or cgmp guidelines are found to be violated.

cgmp guidelines comprises of the general requirements for manufacturing of a drug or a medical device, food and active pharmaceutical ingredients, diagnostics. Good manufacturing practices guidelines are general guidelines with which manufacturer is required to comply with but are not how to comply with them guidelines, a pharmaceutical manufacturer may adapt their own quality systems so as to comply with good manufacturing guidlines, good manufacturing guidelines are more or less similar world wide.

Regulatory agencies (FDA's ) around the world, can inspect the manufacturing firms for compliance of good manufacturing practices with or without prior notice in a reasonable time (when ever the firm is open for a business or activity).


Current good manufacturing practices regulations for combination products.
There is no separate cgmp guidelines regulations for combination products , but the each and every part of the combination product is required to comply separately as a single entity with respective good manufacturing practices guidelines, which include 21 cfr part 210 and 211 good manufacturing guidelines for drugs or pharmaceutical finished product, and 21 CFR Parts 600-680 which provides good manufacturing practices guidelines for biological products , 21 CFR Part 820 for Quality system (QS) regulation for medical devices , when a biological product is developed in to a medical device it is required to follow comply and follow good manufacturing practices guidelines 21 CFR Parts 600-680 as well as 21 CFR Part 820 together.
How to calculate yield and stability of drug part in a combination product: They are required to comply with 21 CFR 211.103 regulations as well as 21 CFR 211.166 for stability of the drug.

Corrective and preventive actions (CAPA) for combination products:
For medical device in a combination product 21 CFR 820.100 describes Corrective and preventive actions (CAPA) and for drug product it is given as a general guidelines in Production Record Review (21 CFR 211.192).


Latest updates by US FDA on current good manufacturing practices freshly issued guidelines:

U S FDA has issued a fresh good manufacturing practices guidelines for Transdermal drug delivery systems, transmucosal drug delivery systems, and for all other related drug delivery systems like drug sprays and application, where drug affect by systemic absorption in to blood .
US FDA has now requires that the initial drug load in the Transdermal drug delivery systems be minimum and rational, and they require that the residual drug load must be mentioned along with the logical explanation for getting an approval for such drugs Read in detail what all about here
Good manufacturing practices guidelines on Transdermal drug delivery system
We have outlined in brief all the sections of 21 CFR part 211 topics which of current good manufacturing practices they address.


Current Good manufacturing practices for penicillin and betalactum drugs:


There are following requirements for manufacturing as well as repacking of penicillin drug products
It requires that there must be complete control on all process so as that cross contamination of other drug with betalactum and penicillin drug do not occur.

US FDA’S 21 CFR 211.42(d) require that there must be separation of facility and equipment for manufacturing of betalactum and penicillin drugs.

21 CFR 211.46(d) Require that there must be separate AIR Handling system for manufacturing aria where betalactum and penicillin drugs are manufactured

21 CFR 211.176: Require that the tests must be in place to find out absence or traces of penicillin where ever there are chances of exposure.

At the same time active pharmaceutical ingredient are also required to be manufactured with similar requirements so as to prevent cross contamination


When some one is sick he goes to a doctor and doctor after diagnosis suggest some treatment and some medicines, importance of those few tablets and syrup or an injection is well understood by the patient and their kiths and kin, these medicines are some times life saving drugs and medical devices, the few milligram dose of the active constituent in the drug and the support of a medical device is very critical for patient, what will happen when those drugs them self become life threatening to them. Example thalidomide.

Therefore along with development of pharmaceutical industry almost every country in world is regulating the drugs and medical devices food and active pharmaceutical ingredients, diagnostics, which their citizens use or consume. United States Food and Drugs Administration is one of the best regulatory agency amongst all in world in medicine and medical device regulations example is the rejection of drug contain thalidomide by US FDA in 1960 while it was approved in European and other countries which is one of the best example how US FDA take care of health of American citizens, otherwise at that time, just like other part of world, several children would have been born in country without limbs and limb deformities because of consumption of drug thalidomide by pregnant mothers, (the one who rejected thalidomide is a women US FDA employee at that time).

Apart from approval of any new drug, regulatory agencies around world form regulations for pharmaceutical and medical devices, active pharmaceutical ingredients, diagnostics, manufacturing which guide manufacturers about what precautions they must take for safe and efficient production of drugs and medical devices active pharmaceutical ingredients, diagnostics with which the manufacturer will be able to ensure and assure them selves as well as rest of the world that the medicines and medical devices, active pharmaceutical ingredients, diagnostics being manufactured or been manufactured at their premises are completely safe effective, and complies to required quality standards at any given times span of the self life of the drug or medical device active pharmaceutical ingredients, diagnostics, these guidelines are called as good manufacturing practices which are abbreviated as gmp guidelines, gmp guidelines constitute guidelines for making foolproof quality assurance systems or quality systems.


Important constitution of good manufacturing guidelines are more or less similar world wide, with the ultimate goal of achieving production of quality drugs . The good manufacturing practices guidelines keeps on changing with time toward improvement as and when there is some improving or up gradations happening in the manufacturing and quality assurance systems and there for one which is updated with such improvising factors and changes are called as current good manufacturing guidelines.

Good manufacturing practices guidelines (gmp guidelines) are integral part of any quality systems therefore failure of the quality assurance system or quality system is critical and damaging to the basis of the quality assurance in turn quality of drugs and medical devices manufactured, and hence would not be affordable and acceptable by either manufacturer or regulatory agencies.

Therefore quality assurance systems are rooted up to the ultimate bases of the all functions which are related to medical device and pharmaceutical manufacturing, therefore origin of the quality assurance in a pharmaceutical and medical device company is at almost at every point and stages involved in medical device and pharmaceutical manufacturing. Therefore the personnel’s responsible for timely production must be trained as prime quality building personals in to quality assurance systems.

Some of the basics common arias of good manufacturing practices are as follows.

1.Quality assurance general Principles , the guidelines outline basic fundamental requirements of quality assurance in a pharmaceutical and medical devices food , and active pharmaceuticals manufacturing.

2.Quality control principals , good manufacturing practices guidelines gives basic detailed requirements of quality control department and what is required and expected functions of the quality control department in a pharmaceutical company.

2. Sanitation and hygiene is one of the major aria of inspection by FDA

3. Validation, process validations basic requiems we have published complete detailed information about process validation and software validation requirements , cleaning validation in pharma.

4. Complaints, handling of market complaints, guides about how to handle any market complaints about drug product.

5. Contract production and analysis guidelines guide about what are the requirements when a pharmaceutical manufacturer gets pharmaceuticals or food, medical devices , it clearly specify the responsibilities of both contract manufacturer and contract giver.

6. Self-inspection and quality audits, which are very important in building a full proof quality assurance system.

7. Personnel, personnel training, personal hygiene. Guidelines about personal hygiene health check ups and

8. Premises. Good manufacturing practice guidelines on premises specify how good and separated , clean should be the premises so as to prevent cross contamination and proper segregation and storage of goods and materials is facilitated. It also gives separately all requirements for sterile dosage forms and aseptic arias and clean room required in sterile drug manufacturing.

9.Equipments: GMP guidelines on equipments gives complete requirement of their cleaning maintenance , preventive maintenance, validation, and documentations in production as well as in process testing and quality control testing.

10. Materials, good manufacturing practices guidelines about materials guide about material including starting material, in process product to finished products in good manufacturing practices guidelines great emphasis is given o material handling , storage and issue and recalled material include all materials including raw material, packaging and finished products.

11.Documentation : Good manufacturing guidelines about documentation provide in details about what types of documents, are required and how those should be generated and how to preserves and utilize them, including documents generated from computer system and standard operating procedures ( sop ) .

The world health organization good manufacturing practices guidelines are followed approximately in hundred developing countries, while EU GMP is followed in the countries under European Union, In US c gmp guidelines issued by US FDA are followed and in U.K good manufacturing practices guidelines are termed as orange guidelines.

ICH good manufacturing practices are followed by countries which are signatories to International Conference on Harmonization ICH (In European union countries , US and Japan) , Australia, Canada, Singapore have adapted the ICH GMP guidelines.


In United States pharmaceutical companies are required to comply with the various good manufacturing practices and regulation for food and drugs.The 21CFR PART 211 provides in details guidelines about current good manufacturing practices for finished pharmaceuticals.

The bulk drug and active pharmaceutical ingredients which are not subject to 21 cfr 210 and 211 regulations but must comply with general standards of current good manufacturing practice.




21CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart A--General Provisions

21CFR PART 211 Sec. 211.1 Scope.

21CFR PART 211 Sec. 211.3 Definitions.

21CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED PHARMACEUTICALS
Subpart B--Organization and Personnel
21CFR PART 211 Sec. 211.22 Responsibilities of quality control unit.

21CFR PART 211 Sec. 211.25 Personnel qualifications.

21CFR PART 211 Sec. 211.28 Personnel responsibilities.

21CFR PART 211 Sec. 211.34 Consultants.

21CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED PHARMACEUTICALS
Subpart C--Buildings and Facilities
21CFR PART 211 Sec. 211.42 Design and construction features.
21CFR PART 211 Sec. 211.44 Lighting.
21CFR PART 211 Sec. 211.46 Ventilation, air filtration, air heating and cooling.

21CFR PART 211 Sec. 211.48 Plumbing.
21CFR PART 211 Sec. 211.50 Sewage and refuse.

Sec. 211.52 Washing and toilet facilities.
40 CFR part 141.
21CFR PART 211 Sec. 211.56 Sanitation.
21CFR PART 211 Sec. 211.58 Maintenance.

21CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED PHARMACEUTICALS
Subpart D--Equipment
21CFR PART 211 Sec. 211.63 Equipment design, size, and location.
21CFR PART 211 Sec. 211.65 Equipment construction.
21CFR PART 211 Sec. 211.67 Equipment cleaning and maintenance.

21CFR PART 211 Sec. 211.68 Automatic, mechanical, and electronic equipment.
21CFR PART 211 Sec. 211.72 Filters.


21CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart E--Control of Components and Drug Product Containers and Closures

21CFR PART 211 Sec. 211.80 General requirements.
21CFR PART 211 Sec. 211.82 Receipt and storage of untested components, drug product containers, and closures.
21CFR PART 211 Sec. 211.84 Testing and approval or rejection of components, drug product containers, and closures.
21CFR PART 211 Sec. 211.86 Use of approved components, drug product containers, and closures.
21CFR PART 211 Sec. 211.87 Retesting of approved components, drug product containers, and closures.
21CFR PART 211 Sec. 211.89 Rejected components, drug product containers, and closures.
21CFR PART 211 Sec. 211.94 Drug product containers and closures.

21CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED PHARMACEUTICALS
Subpart F--Production and Process Controls
21CFR PART 211 Sec. 211.100 Written procedures; deviations.

21CFR PART 211 Sec. 211.101 Charge-in of components.
21CFR PART 211 Sec. 211.103 Calculation of yield.

21CFR PART 211 Sec. 211.105 Equipment identification.
21CFR PART 211 Sec. 211.110 Sampling and testing of in-process materials and drug products.
21CFR PART 211 Sec. 211.111 Time limitations on production.
21CFR PART 211 Sec. 211.113 Control of microbiological contamination.

21CFR PART 211 Sec. 211.115 Reprocessing.

21CFR PART 211 21CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED PHARMACEUTICALS
Subpart G--Packaging and Labeling Control
21CFR PART 211 Sec. 211.122 Materials examination and usage criteria.
21CFR PART 211 Sec. 211.125 Labeling issuance.
21CFR PART 211 Sec. 211.130 Packaging and labeling operations.
21CFR PART 211 Sec. 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
21CFR PART 211 Sec. 211.134 Drug product inspection.
21CFR PART 211 Sec. 211.137 Expiration dating.

21CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart H--Holding and Distribution
21CFR PART 211 Sec. 211.142 Warehousing procedures.

21CFR PART 211 Sec. 211.150 Distribution procedures.
21CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED PHARMACEUTICALS
Subpart I--Laboratory Controls
21CFR PART 211 Sec. 211.160 General requirements.
21CFR PART 211 Sec. 211.165 Testing and release for distribution.
21CFR PART 211 Sec. 211.166 Stability testing.

21CFR PART 211 Sec. 211.167 Special testing requirements.
21CFR PART 211 Sec. 211.170 Reserve samples.

21CFR PART 211 Sec. 211.173 Laboratory animals.
21CFR PART 211 Sec. 211.176 Penicillin contamination.

21CFR PART 211 21CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart J--Records and Reports
21CFR PART 211 Sec. 211.180 General requirements.
21CFR PART 211 Sec. 211.182 Equipment cleaning and use log.

21CFR PART 211 Sec. 211.184 Component, drug product container, closure, and labeling records.

21CFR PART 211 Sec. 211.186 Master production and control records.
21CFR PART 211 Sec. 211.188 Batch production and control records.
21CFR PART 211 Sec. 211.192 Production record review.
21CFR PART 211 Sec. 211.194 Laboratory records.
21CFR PART 211 Sec. 211.196 Distribution records.
21CFR PART 211 Sec. 211.198 Complaint files.
21CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED PHARMACEUTICALS
Subpart K--Returned and Salvaged Drug Products
21CFR PART 211 Sec. 211.208 Drug product salvaging.



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