GMP Consultants in Bangalore and India
Our Inzinc Consulting India team comprises of Pharmaceutical subject matter experts who are expert Good Manufacturing Practices or GMP Consultants in Bangalore and other cities in India. These consulting sessions put a solid foundation of best Pharmaceutical practices in an Organization through which they can realize their Operational objectives.
What is Good Manufacturing Practices or GMP ?
Good Manufacturing practices (GMP) are the guidelines for the Manufacturing industries more specifically for industries manufacturing the materials for the medicinal use, APIs (Active Pharmaceutical ingredients) and the drug products.
Why GMP ?
Tragic events have resulted due to various malpractices and labelling issues causing deaths and serious health hazards in the early industrialisation era in the world. These instances imposed the formation of couple of guidelines for labelling and marketing always in the reactive ways. These guidelines were also restricted to the region/country.
One landmark incident that sent shivers in the humanity was the Thalidomide disaster that happened in 1962. The effect of the disaster was ‘phocomelia’, that is shortening or absence of limbs in children born during that period. The mothers had consumed the medicine as sleeping pills/tranquilizers.
Tylenol incident in 1982 and went on with sporadic instances up to more than a decade causing death of personnel consuming the medicine that was laced with cyanide. The Company went on to recall the product from the market and incurred huge loss. Tylenol was sold as OTC drug that was used as pain killer.
We can also recall mess-ups in manufacturing practices as early from 1986 Glycerin Adulteration and 1996 mix up of Glibenclamide in the shop floor. These are critical events showing severe lapses in manufacturing practices.
This also shows the dearth of proper regulations in that time period (early and mid-20th century). Regulations started taking shape in various countries and regions and accelerated in formulate rigorous systems for Drug approval and monitoring.
So Good Manufacturing Practices are required to be implemented by the Manufacturer to comply to the regulations and also have a planned Quality program or structure to achieve Organisational Objective.
Simple rules of GMP
- Have adequately planned facility for operations, where the activites are segregated to prevent the cross contamination. This is to ensure appropriate physical environment for personnel and equipment
- Have facility, equipment and processes validated to get the intended results consistently by following a plan
- Develop procedures and follow them
- Assign job responsibilities and ensure the personnel understand them
- Train personnel for their roles and have a continuous training and development plan to keep them abreast at all the times
- Sensitize personal hygiene and cleanliness and have monitoring program
- Maintain the facility and equipment in optimum condition to ensure ready availability
- Design quality in to the product right from the raw material stage till its distribution
- Keep records for complete life cycle of the final product (Identification and traceability)
- Conduct regular audits/self-inspections and take necessary actions to resolve the nonconformities
Benefits of GMP Consulting for an organisation
- Consistent Quality, safety and efficacy of the products
- Credibility in the Market
- Readiness for Regulatory inspections anytime
Typical Stages of the GMP Consulting Project
- Gap Audit
- GMP training
- Support in developing / reviewing existing procedures / SOPs for adequacy
- Final Review of documents
- Periodic Audits
To contact our GMP Consultants in Bangalore, Mumbai, Chennai, Hyderabad and other cities in India, please drop an enquiry to email@example.com