Offering GMP/ Quality Auditing, Quality System Implementation, GMP Training and Remediation/Problem solving services for Food and Pharmaceutical Industry
Area Of Expertise
Quality Audits
Performing audits of food and pharmaceutical companies, raw material and packing material suppliers of all types in any geographical region, globally. These can be on site audits, desktop audits or Remote Audits – the new type of audits necessitated by the COVID 19.
Preparing sites for audits, and certifications.
Training teams on facing audits and preparing trained auditors.
QMS Implementation
Implementation of Quality Management Systems based on the company QMS, regulatory requirements.
Quality Documentation: Manual, SOPs, Work Instructions and designing and preparation of Quality Records
Specific gap analysis against any given standard and making action plans for plugging the gaps
Training
Development of training modules related to Quality, Technical Aspects, Quality Mindset, and Culture.
Imparting of training – onsite or remotely
Identifying training needs and implementation of training programs and calendars
Data Integrity
Creating understanding of the need for Data Integrity. Data Integrity Principles. Developing Data Integrity Action Plans. Specific Data Integrity Audits
Microbiology
Solving microbiological problems related to product Quality.
Other Areas
Implementing General and Quality Risk Management programs.
Implementing Remediation plans for sites having multiple or repeat problems.
Process Improvement projects for Quality Improvement.
