Good Manufacturing Practice (GMP)

Introduction

Good Manufacturing Practice (GMP) Is a manufacturing and testing process that helps to ensure a product of quality. GMP guidelines are not prescriptive instructions for how to manufacture goods. There is a set of general concepts that have to be followed during production. When a company develops it's a quality system and manufacturing methods, it can be able to satisfy GMP requirements in several ways. It is up to the company to determine the most efficient and effective quality process.

For the pharmaceutical industry, GMP is a key term. Good Manufacturing Practice (GMP) is, according to the World Health Organization (WHO), a mechanism to ensure that products are produced and regulated in a safe manner according to quality standards. The main purpose of this is to reduce the risk involved in pharmaceutical production, which by testing the final product is difficult to eliminate. Severe consequences that exist in the absence of provisions such as cancelation of the license, restriction of the drug, or claim of neglect or failure to comply.

For manufacturer Ayush Sidha Unani (ASU) drugs described in rule 157 of drugs & cosmetics rule 1945 with conditions as specified in schedule T/ GMP are to ensure that;

➲ The authentic raw material of prescribed quantity and free from contamination has been used in the manufacturing of drugs

➲ The manufacturing process is as prescribed to maintain the standards

➲ The manufacturer has adopted adequate quality control

➲ The produced drugs that are released for sale are of acceptable quality

Who needs GMP:

➲ Drug Manufacturer

➲ Ayush Manufacturer

➲ Drug Importer

➲ Medical equipment manufacturer

➲ Personal Protection Equipments

Importance of GMP

Unlike conventional pharmaceutical products, which are typically made from synthetic materials by reproducible manufacturing techniques and procedures, ASU medicines are mainly prepared from materials of herbal origin, often obtained from a variety of geographical and/or trade sources.

Subsequently, it may not always be possible to establish 3 of the conditions to which they may have been subjected. Additionally, composition and properties can vary. In addition, the methods and techniques used in the manufacture and quality assurance of ASU medicinal products are also substantially different from those used for conventional pharmaceutical products.

Benefits of GMP certification

➲ Prove management skills of the association in item quality, wellbeing assurance

➲ Encourage members to grow great creation/tasks propensities

➲ Timely recognition of creation and management issues

➲ Better understanding and compliance with essential laws and guidelines

➲ Boost overall reputation and the public image

GMP Principals

All manufacturer should follow a few basic guidelines as per GMP:

➲ All recommendations follow a few basic principles: any risk to their quality must be restricted by the processing and distribution of the medicines. Manufacturing offices, including laboratories and power, must maintain a perfect and clean manufacturing zone.

➲ The agency of pharmaceutical manufacturing must keep the manufacturing zone clean and spotless. Controlled ecological conditions to avoid cross-contamination from adulterants of the nourishment or drug item which can make the item unsafe for human use.

➲ The process of manufacturing is unmistakably characterized and controlled. To ensure accuracy and consistency with the details, every single basic procedure is approved.

➲ Manufacturing processes are tracked, and any change to the process is evaluated. Changes that affect the medication's function are accepted as necessary.

➲ Written techniques and directions are clear and unambiguous

➲ Document procedure needs to be prepared and conduct by administrators.

➲ Operators should be trained in manufacturing and evaluating goods according to documented and approved procedures.

➲ During manufacturing and quality control records should be made, showing that all the necessary steps needed by the prescribed procedures and instructions have been performed as prescribed and that the product's stated quality attributes have been met. Deviations are under investigation and are documented.

➲ Process should remain in a state of control throughout the product lifecycle and improvements done as needed.

➲ Manufacturing records (including distribution) are stored in a comprehensible and usable format capable of tracing a batch's entire history.

➲ A recalling system must be available for recalling any batch from sale or supply.

➲ Complaints about marketed products should be examined, the causes of quality defects investigated, and appropriate action taken against faulty goods should be addressed, and recurrence prevented.

Procedure for certification;

Step-1 This is the first step to get the GMP certification, the application covers some basic information of the company. The certification body must approve the application and must b record or maintain all of the GMP database information.

Step-2 The application received shall be reviewed by the team to ensure that the compliance requirement has been fulfilled.

Step-3 After the review of documents we provide the price quotation to the client and performs the Gap Analysis to cover all the clauses and section of the quality standards and Gap Analysis is conducted to test the difference between the plans expected for the business and the plans accomplished.Step-4 Stage 1 Audit: Evaluate your organization's documented procedure and policies against the compliance requirement.

➲ Review the documentation of your management system to ensure that the compliance requirement has been contented.

➲ Corrective action:- Corrective action is deal with the non-conformity. It has taken when the non-conformity occurs.

➲ Verification:- Verify the documentation of the organization as per the standard requirements.

Granting of certificate: If all audit and reviews are conducted well with clear report then certifying authority may grant the GMP certificate which will be valid for 3 years