Virtutis Pharmaceuticals follows current GMP guidelines for the manufacturing of pharmaceutical products as recommended by the regulatory agencies. Our GMP system ensures compliance as per current legislation and authorizations for manufacturing and marketing of active pharmaceutical ingredients and well as finished formulations.
Our objective for following good manufacturing practices (GMP) is to ensure consistency in production of pharmaceutical products of high quality. Through GMP we reduce the risks during the production that cannot be eliminated by testing the finished goods.
About our GMP System
The main risks which can arise during the production of pharmaceuticals are cross contamination and mix-ups due to false labeling. Thus, compliance with GMP helps in minimizing these risks. Products can be declared as adulterated by the courts, even if they have no regulatory issues but are not produced as per the GMP rules.
The detailed written procedures of GMP are separately available for every aspect of production including starting materials, equipment, premises, personal hygiene of the staff and their training. Compliance to GMP is essential at each and every step of the manufacturing process of both active pharmaceutical ingredients (APIs) and for finished pharmaceutical products. Systems are adopted by the pharmaceutical companies, to provide documental proofs of being compliant.
Our key stones are :
- The manufacturing processes are clearly defined and reviewed systematically, that ensures the consistent production of quality products. Any changes to the manufacturing process are evaluated and validated as necessary if they have an impact on the quality of the product.
- All the required resources including the premises, materials and equipment, and personnel are provided.
- A clean and hygienic manufacturing area is maintained.
- Qualification and validation are performed.
- Cross contamination with unlabelled allergens is prevented.
- The instructions are provided clearly in written form, regarding the facilities available.
- Training is provided to the operators on how to carry out the procedures accurately.
- A system is available, to recall the supplied products if required.
- Complaints on the marketed products are assessed, and necessary actions are taken considering the defective products to prevent further such defects during the manufacture.
- Instructions for the storage and distribution of the products are clearly provided to prevent any damage.
- Records are maintained on the manufacture, storage, supply of all the products which help in tracking them in future.
Training & Documentation
All the personnel including the technical staff, maintenance and cleaning staff members are trained by internal and external consultants to optimize our compliance in theory and practice in terms of GMP roles. Training records are maintained to keep a track of the ongoing training. Our training is a continual process, and its effectiveness is assessed periodically.
Proper documentation is essential for all the aspects of GMP as a part of quality assurance system.
The documents are approved, signed and dated by the appropriate persons. They are regularly reviewed and updated.
Regular auditing to improve the level of GMP
Our organizations proactively put constant efforts to improve the GMP level. As a part of this, internal audits (self-inspections) are conducted by qualified auditors at least once every year. A checklist is used by the auditor in conducting a thorough and systematic audit. Following this, the corrective and preventive actions (CAPAs) are implemented wherever necessary.
Apart from this, the other ways adopted include inspections from national competent authorities and external audits by third parties or customers. Any deviations or customer complaints are rectified as a part of CAPA.
A follow-up of the CAPA is performed by annual reviews which may include product reviews, management reviews, utility reviews, etc. to effectively manage the audits. Any discrepancies detected, need the employees to be further trained in the respective SOPs.
The drug inspectors from competent health authorities regularly inspect our manufacturing facility for compliance with the GMP rules.
Compliance to the GMP is essential for the production of quality standard products as per their intended use. Due to the constant development in the GMP in the intervening years, it is required to revise and update these national and international principles regularly.