GMP

EQACL provides and assist organization in obtaining Good Manufacturing Practices (GMP) which is necessary to meet the concerned authorities that control the approval and license for the manufacture and sale of food, medicines and active pharmaceutical goods. GMP sets a practical guide line. These guidelines set the minimum requirements that must be met by a pharmaceutical or food manufacturer to ensure that the products are of high quality and do not pose a risk to consumers or to the public.

Good manufacturing practices and good agricultural practice, good laboratory practice and good clinical practice are monitored by the supervisory authorities in most of the countries.

It is considered as one of the main approval for export and import of various goods and even for selling goods inside the country. Good Manufacturing Practices (GMP) is the quality assurance section which ensures that products are manufactured and tested to appropriate for their uses, from other members of the input quality standards.

GMP primarily reduce the risk of pharmaceutical production that can be divided into two groups: cross-contamination / confusion and false labeling. In particular, manufacturers should not endanger the patients due to inadequate safety, quality or efficacy; for this reason, the risk assessment has played an important role in the WHO Guidelines for quality assurance.

The guidelines for good manufacturing practices provide specifications for production, testing and quality assurance, whether to ensure a product or food and drug safe for human consumption. Many of the countries that regulate food regulated foodstuffs and pharmaceutical medicines follow the GMP procedure .

Basic principles of GMP followed by EQACL for certification

•  Manufacturing facilities must maintain a clean and hygienic manufacturing area.
•  Controlled environmental conditions in order to prevent cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption.
•  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 affect the quality of the drug are validated as necessary.
•  Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
•  Operators are trained to carry out and document procedures.
•  Cross contamination with unlabelled major allergens is prevented.
•  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 food or 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 food or drugs minimizes any risk to their quality.
•  A system is available for recalling any batch from sale or supply.
•  Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.

For WHO Guide line for good manufacturing practices for pharmaceutical products: main principles can be downloaded by clicking

http://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf

In 1992, the revised draft requirements for GMP were presented in three parts, of which only parts 1 and 2 are reproduced in this document (1). “Quality management in the medicines industry: philosophy and essential elements”,outlines the general concepts of quality assurance (QA) as well as the principal components or subsystems of GMP, which are joint responsibilities of top management and of production and quality control management. These include hygiene, validation, self-inspection, personnel, premises, equipment, materials and documentation .These two parts were subsequently supplemented by further guidelines which are integral parts of these GMP for pharmaceutical products. All these texts are available on the Medicines web page (http.www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpcover.html).

“Good practices in production and quality control”, provides guidance on actions to be taken separately by production and by quality control personnel for the implementation of the general principles of QA.

Current good manufacturing practices (GMPs), which require that companies have proper controls for the manufacturing, packaging, labelling, and storing of dietary supplements, are a key facet of product safety. FDA first introduced GMP regulations for dietary supplements (21 CFR Part 111) in 2007, with the intent of industry-wide compliance by 2010. By now, all companies should be GMP compliant.

Benefits of GMP Certification

While the law in many countries dictates that dietary supplement companies and pharmaceutical must meet their GMP obligations, it does not require that a manufacturer be certified as GMP compliant,however, that third-party certification is an important step beyond self-monitoring.

Certification validates that products manufactured match the identity, composition, potency, and purity declared on the product label. It also ensures that the processes, procedures, and documentation required for GMP compliance are in place and effective. Certification not only supports a company’s credibility in the marketplace; it also promotes the credibility of the supplement industry as a whole.

Investing in a third-party certification audit to confirm compliance with all of FDA’s regulations has one important additional benefit: it provides an objective, fresh set of eyes on the facility and its safety parameters. Even a company with excellent quality systems in place can gain wisdom from the additional perspective an auditor can provide.

The third-party audit not only serves to validate GMP compliance but also provides guidance for continuous process and documentation improvement.

Businesses that sell supplements directly to consumers want the assurance that the companies supplying those products are complying with the highest standards available. Certification sends a strong message that the investment and commitment have been made to assure safety and regulatory compliance.

EQACL inspect a company’s facility multiple times a year to ensure regulatory compliance as well as product and ingredient safety. Through this process, a company can learn about the things it is doing well and the things upon which it can improve.

The rigor and scrutiny that come with this oversight help keep a company sharp. It ensures companies stay up to date on the regulations and keeps the industry mindful of how best to maintain the high degree of quality of the products being purchased and consumed.

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