We help the firms in designing their documentation system to meet international standards of US FDA, WHO, EU, PICS, TGA, ICH Q7, MHRA. The documents shall include QMS, Batch documentation, Validation, Recording forms and formats and SOPs and all relevant /associated GMP documentation. We review the firms SOPs for performance and compliance. We provide the firms prototypes ( templates ) of few SOPs based on which the firms are expected to prepare and expand their SOPs.
We also assist the firm in preparing master GMP documentation where required. Once the SOPs are prepared by the firm, they shall be reviewed by us to ensure that they are in regulatory compliance, technically accurate and resources are available for their execution.
The documentation team ( personnel who prepare and review GMP documents )of the firm shall be trained, which in turn shall help the firm in continuously improving and sustaining their GMP documentation.
We work closely with experienced and highly skilled professional and global GMP experts to benefit our clients from their comprehensive and practical knowledge and expertise.
We also help firms in translating GMP documents in Marathi and Hindi to help in familiarizing the workmen team members in the SOPs they use. In addition, we develop trainers to conduct on the job SOP training.
A cost effective method and approach is adopted towards documentation for the firms benefit.
Advantages of GMP Documentation
Reduction in time spent on documentation
Reduction in struggle and basic errors to achieve compliance