Standard Operating Procedures
Standard Operating Procedures (SOPs) need to be designed carefully, so that they fulfill regulatory compliance and have on floor applicability. A SOP should be easy to read and have precise instructions which cover all aspects of the procedure it intends to address.
We work with brand owners, manufacturers, testing laboratories and in-house quality teams to design SOPs that streamline operations and are compliant with local, federal authorities as well as other certification programs such as NSF.
Our SOP services include:
- Drafting of operational SOPs for manufacturing, packaging, labelling and distribution of food and natural health products for new and existing facilities
- Review of existing SOPs to optimize and ensure regulatory compliance and operational efficiency
- Identify gaps in procedures and provide solutions to bridge them to prevent procedural discrepancy
GMP Compliance
Whether it is GMP compliance for general operations or licensing and certifications, we have you covered. We provide documentation compliance review and on-site employee training to help bring operations up to speed with Health Canada and the US FDA regulations. Our GMP services include:
- Preparation and review of SOPs for manufacturing, packaging, labelling, testing and distribution of natural health products.
- Review of third party testing of raw materials, intermediate products and finished products
- Label review for GMP and regulatory compliance, with Health Canada, US FDA and COFEPRIS labeling checklists
- Site visits for facility inspection to verify GMP compliance and audit preparedness
- Employee in house training for GMP compliance, personnel and operation specific training
- GMP training for Natural Health Products and Dietary Supplements
- GMP training for Health Canada site license compliance and US FDA food facility registration compliance
- HACCP training and PCP protocol development for Safe Food for Canadians (SFCR) licensing
- Help in setting up stability testing platform for natural health products as per ICH guidelines