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
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.
➲ 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
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.
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
We share the detailed and reasonable estimated costs, documents and prerequisites for the complete process before starting the process to ensure transparency.
Our team warrants hassle free documentation. We collect the necessary documents and share the relevant drafts to ensure a timely filing and delivery.
Upon collecting the necessary documents and information, we waste no time in preparation and filing of your application. development on your application is brought to your attention.
On successful completion of the case we share all the relevant documents electronically and physically along with an assurance to pay you back if something is wrong.
Regulation of medical devices and their quality systems in India was limited compared with other developed nations that typically have very robust approval systems for medical devices in place.Read More
One of the world's leading food protection and quality control programs, the SQF (Safe Quality Food) program which is developed to meet the needs of retailers and suppliers around the world. SQF offers independent certification that a product, process,Read More
Food safety is a regular concern not only for consumers but for every food industry stakeholder as well. Feed safety is equally important for animal products, especially in the light of the various food scandals that have occurred in the past years. The ERead More
The National Health Authorities grant this CoPP certificate upon request from the consumer, the authorities, or the drug supplier in the importing country. This certificate refers to a particular product whether or not it is sold in the country of originRead More
Hallmarking is a way of preserving the buyers' interest. BIS Hallmark is a device that lets you assess the pureness of the country's gold and silver gems. It is a certification issued by India's national quality organization Bureau of Indian Standards (BIRead More
External commercial borrowings are loans made to the Indian borrowers by non-resident lenders in convertible foreign exchange. It’s an instrument through which Indian borrowers avail loans from a foreign entity or from foreign sources.Read More
DRDO is the Ministry of Defense's R&D department, Govt of India, with a vision to empower India with state-of-the-art weapons systems and a mission to achieve self-reliance on critical defense technology and systems, while equipping our armed forcesRead More
BIS is a national body that ensures the quality, safety, and reliability of Indian goods. BIS is intended to analyze product samples while they are in the preliminary and surveillance stages. India has 8 centre, 4 regional, and 3 BIS branch laboratoriesRead More
In India, a non-profit organization GS1 which is the organization of ministry of commerce and industry manages and standardizes barcode. It was established in 1996. GS1 sets standards and manages the barcode standard used by retailers, manufacturers, andRead More
Good Manufacturing Practice (GMP) Is a manufacturing and testing process which helps to ensure a product of quality. GMP guidelines are not prescriptive instructions for how to manufacture goods. There are a set of general concepts that have to be followeRead More
The National Organic Program (NOP) is a federal legislative system for organic food in the United States of America. It is also named after the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) system responsible for theRead More
TEC stands for Telecommunication Engineering Center. TEC facilitates the development and enforcement of various standards and policies by the Department of Telecommunications, Government of India, for the safe and efficient use of emerging telecommunicatiRead More
The Agricultural & Processed Food Products Export Development Authority (APEDA) is a government agency founded in 1985 to develop and facilitate the export of scheduled goods. It offers financial support, information and advice on the productionRead More
SITRA stand for South India Textile Research Association, established in 1956 is governed by a council administration consisting of member representative of the industry, government and scientists.Read More
The WPC (Wireless Planning & Coordination) is a division of communications and information technology ministry, telecommunications department, India. Wireless Planning & Coordination involves the planning, managing, and monitoring of radiofrequency and geRead More
Uniquely repurpose strategic core competencies with progressive content. Assertively transition ethical imperatives and collaborative manufactured products.Write About Us
© 2022 Corpzo Ventures Private Limited.