If a Pharmaceuticals Company isn't following cGMP, are there drug products safe for use?

If a company is not complying with cGMP regulations, any drug it makes is considered “adulterated” under the law. This kind of adulteration means that the drug was not manufactured under conditions that comply with cGMP. It does not mean that there is necessarily something wrong with the drug.

For consumers currently taking medicines from a company that was not following cGMPs, FDA usually advises these consumers not to interrupt their drug therapy, which could have serious implications for their health. Consumers should seek advice from their health care professionals before stopping or changing medications. Regulatory actions against companies with poor cGMPs are taken as a preventive measure because the manufacturing processes do not meet FDA’s regulatory standards. By focusing on the procedures and processes used to make these drugs, FDA is working to ensure that drugs meet their quality standards and are safe and effective. The impact of cGMP violations depends on the nature of those violations and on the specific drugs involved. A drug manufactured in violation of cGMP may still meet its labeled specifications, and the risk that the drug is unsafe or ineffective could be minimal. Thus, FDA’s advice will be specific to the circumstances, and health care professionals are best able to balance risks and benefits and make the right decision for their patients.

How does FDA determine if a company is complying with cGMP regulations?

FDA inspects pharmaceutical manufacturing facilities worldwide using scientifically and cGMP trained individuals, whose job it's to evaluate whether the company is following the cGMP regulations. FDA also relies upon reports of potentially defective drug products from the public and the industry. FDA will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the cGMP regulations.

Why cGMP so Important?

I discussed shortly....

A consumer usually can't detect that a drug product is safe or if it will work.  While cGMP require testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the cGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how cGMP requirements help to assure the safety and efficacy of drug products.

The factors about cGMP.

Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every people. Consumers expect that each batch of medicines they take will meet quality standards, so that they will be safe and effective. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs. This paper discusses some facts that may be helpful in understanding how cGMPs establish the foundation for drug product quality.

      cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

   The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "c" in cGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.

It is important to note that cGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.

What is a Change Request?

Change Control is a general term describing the process of managing how changes are introduced into a controlled System. In validation, this means how changes are made to the validated system. Change control is required to demonstrate to regulatory authorities that validated systems remain under control after system changes. Change Control systems are a favorite target of regulatory auditors because they vividly demonstrate an organization capacity to control its systems.

What's Validation Summary Report?

Validation Summary Reports provide an overview of the entire validation project. When regulatory auditors review validation projects, they typically begin by reviewing the summary report. The validation summary report should include:

    A description of the validation project

   All test cases performed, including if those test cases passed without issue

   All deviations reported, including how those deviations were resolved

What's a PQ Document?

Performance Qualifications are a collection of test cases used to verify that a System performs as expected under simulated real-world conditions. The performance qualification tests requirements that were defined in the User Requirement Specification (or possibly the Functional Requirements). Due to the nature of performance qualifications, these tests are sometime conducted with power users as the system is being released.

What's an OQ Document?

Operational Qualifications are a collection of test cases used to verify the proper functioning of a System. The operational qualification tests requirements defined in the Functional Requirements. Operational Qualifications are usually performed before the system is released for use.

What's Validation Plan?

Validation Plans define the scope and goals of a validation project. Validation plans are written before a validation project and are specific to a single validation project. Validation Plans can include:

    Deliverable s (Documents) to be generated during the validation process

   Resources/Departments/Personnel to participate in the validation project

   Time-Line for completing the validation project

What are user requirements ?

User Requirements Specification describes what users require from the System. User requirement specifications are written early in the validation process, typically before the system is created. It is written by the System Owner and End Users, with input from Quality Assurance. Requirements outlined in the URS are usually tested in the Performance Qualification. User Requirements Specifications are not intended to be a technical document; readers with only a general knowledge of the system should be able to understand the requirements outlined in the URS.

21 CFR part 11

What is 21 CFR part 11 ?

The title 21 CFR Part 11 is the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records

Some Important terms..

What is an  SOP ?

SOP that means Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-step outline form how to perform a particular task or operation. Everyone in a company must follow the same procedures to assure that tasks are performed consistently and correctly. Most companies have a wide variety of SOPs that describe how to do different tasks. In many companies technicians and operators are trained in how to follow individual SOPs and their training record specifies which SOPs they are trained on and are authorized to use.

Few days later i published some important topics about Industrial Pharmacy, I think which is very beneficial for production pharmacist........

On the others definition...

GMP is defined That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorization or product specification.

 Quality Assurance is defined as:

The sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use.

The formal definition of Quality is:

The totality of features and characteristics of a product or service which bear on its ability to meet stated or implied needs.

Quality Control is the process by which we measure actual quality performance, compare it with a standard and take action if there are any differences. This process of comparison takes place during the production stages and when the product is ready for delivery. At this point we can use the product specification to compare with, at earlier stages there may need to be intermediate specifications.

One of the basic principles of GMP, which is echoed in ISO 9000, is for the responsibility for Quality Control to be held by somebody independent from the people responsible for production. This does not mean that the testing facilities need to be managed independently, but that the acceptance of the results of the testing must be independent, as must the initiation of any actions necessary after examining the results.

GMP REQUIREMENTS

The current version of “Rules and Guidance for Pharmaceutical Manufacturers and Distributors” has nine chapters, which have the following titles:

1. Quality Management

2. Personnel

3. Premises and Equipment

4. Documentation

5. Production

6. Quality Control

7. Contract Manufacture and Analysis

8. Complaints and Product Recall

9. Self Inspection

What is GMP?

Good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. 

There are few number of guidelines that follow a few basic principles:

• Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.

• Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.

• Instructions and procedures are written in clear and unambiguous language.

• Operators are trained to carry out and document procedures.

• Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.

• Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.

• The distribution of the drugs minimizes any risk to their quality.

• A system is available for recalling any batch of drug from sale or supply.

• Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.

Good Manufacturing Practices for Active Ingredient Manufacturers

Firstly i introduced about GMP(Good Manufacturing Practice)

This introductory topics for:

Good manufacturing practices

for

Active ingredient

manufacturers

This introduction reviews the development of Good Manufacturing Practices (GMPs) for Active Ingredients (A.I.s.) and explains the purpose of the present Guideline.

In the USA, although the FDA has not yet issued separate GMP regulations for active ingredients, to assist agency personnel, guidelines have been produced entitled "Guidelines to the Inspection of Bulk Pharmaceutical Chemicals". These were last updated in May 1994.

Guidelines have also been developed in the USA by PhRMA (Pharmaceutical Research Manufacturers Association) entitled "Guidelines for the Production, Packing, Repacking or Holding of Drug Substances" which were published in September 1995.

In Europe the Pharmaceutical Inspection Convention (PIC) issued a "Guideline for the Manufacture of Active Pharmaceutical Ingredients" in June 1987. This document has not been revised since its original publication and provided the basis for the WHO guide cited above.

In the European Union the principles of GMP for medicinal products were laid down in the "Guide to Good Manufacturing Practice for Medicinal Products" in Volume IV of "The Rules governing Medicinal Products in the European Community". This guide states that, for the manufacture of active ingredients, the PIC document was an appropriate reference. This PIC document therefore is, at present, the only official guidance available to all member states of the European Union.

In several countries manufacturers of active ingredients found that the PIC document did not provide sufficient guidance, and thus several organisations in Europe published more detailed guidelines for GMP of active ingredients. These include the French SICOS Biochimie, the Italian Aschimfarma, the UK Pharmaceutical Quality Group, the "Guidance for Bulk Pharmaceutical Chemical Manufacturers" developed in 1994 by CEFIC (the European Chemical Industry Council) and the German VFA (the Association of Research-based Pharmaceutical Manufacturers) document of February 1995: "Recommendations for Good Manufacturing Practices for Active Ingredient Manufacturers". It is this VFA document that EFPIA, the European Federation of Pharmaceutical Industries Association, adopted as the basis for a European Industry Guideline for Active Ingredients.

The present document has been produced by a joint EFPIA/CEFIC working group and reflects the objectives of both associations to produce and publish one guideline suitable for all active ingredient manufacturers. Its purpose is to serve as a guide, with the intention of ensuring that active ingredients are manufactured under a quality assurance system which is appropriate for their subsequent use. The scope is limited to GMPs for active ingredients, excipients are not covered.

The document describes Good Manufacturing Practices for substances intended to be used as therapeutically active ingredients of medicinal products for human use.

Any substance from organic, inorganic, microbiological, animal or plant origin, or material produced by recombinant DNA methods and purported by the producer to provide therapeutic activity is an Active Ingredient, (A.I.) even if it is not recognized or offered as such in every member state of the European Union.

The following recommendations are intended to serve as a guide for the European active ingredient manufacturing industry with the intention of ensuring that active ingredients are manufactured under a quality assurance system which is appropriate for their subsequent use. 

These recommendations are also suitable for use in the inspection of active ingredient manufacturers either through a Self-Inspection program or by the designated authorities.

Welcome Speech

Hello everybody . In this blog you can find all information about pharmacy & related topics , specially who new in this field, i just try to get them some information & also some very important topics which help for them who doing job & try to get job in this related field........................