GMP

Lakshy Management Consultant Pvt. Ltd. is one of the largest and leading GMP consultants in India. We are transnational ISO certification consultants with clients in India, USA, UK, Saudi Arabia, Kuwait, Middle East, Europe, Africa, Australia, Singapore, Hong Kong, UAE, Qatar, Oman, Russia etc. We provide quick, result oriented and easy to implement consultation and training for GMP certificate. Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.

GMP is important to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing. The main risks are :-

1. unexpected contamination of products
2. damage to health
3. incorrect labels on containers, which could mean that patients receive the wrong medicine
4. insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects

GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures taken; full traceability of a product through batch processing records and distribution records; and systems for recall and investigation of complaints.

Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process, every time a product is made.

The principle of GMP is that quality is built into a product, and not just added to a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made.

• Outlines the quality system that reduce and prevent errors
• Ensures products are safe to use for humans
• prevents/controls contamination or cross contamination
• minimalizes variations in potency of the drug
• prevents side effects and toxicity due to variations in drug contents and potency
• prevents mislabeling and adulteration

With a team of highly qualified consultants and trainers having vast industrial experience, Lakshy Management Consultant Pvt. Ltd. assists organizations across the world to implement and achieve GMP certification. Our consulting approach is highly professional, time bound and effective resulting in the ease of implementation and adds value to the business processes of the client’s organization.

We offer GMP training, implementation, consultation, gap analysis, documentation, internal audits, pre-assessment audits, certification audit through best of the certification bodies and post certification enhancement / maintenance services to enable your organization to get the best out of GMP quality management system. Our services are globally accepted, authoritative and benchmarked in the field of GMP

Contact us at info@lakshy.com to get your organization GMP CERTIFIED.