Our services
ALCA Global Supplement Industry Consulting offers our flagship service along with an additional five central services for brands as well as co-manufacturers, co-packagers, and distribution centers:
* Flagship Service: Quality Management System (QMS) Development
* Quality Management System (QMS) Implementation
* Preparation for GMP certification
* GMP and Quality Training
* Develop SQF Food Safety Program
* Consulting
Flagship Service:
Quality Management System (QMS) development to ensure full compliance with FDA GMP regulations and/or GMP certification programs:
Preparation for GMP certification:
* Thorough review of GMP certification program requirements
* Execute all tasks under QMS Development or adapt existing. QMS to meet GMP certification program requirements
* Assist clients with the GMP certification application process and ensuring audit is scheduled in a timely manner
* In-person participation during the GMP certification audit
* Follow-up with any GMP post-certification audit requirements
* A full QMS development project would include:
* Review of any existing Standard Operating Procedures (SOPs) and any other GMP related documents, and revise as needed
* Review existing Master Manufacturing Records and Specifications for raw materials and finished products
* Write all required Standard Operating Procedures (SOPs), forms, process flowcharts, Food Safety Plans (which includes the Hazard Analysis and Risk-Preventive Controls or HARPC), quality manuals, and templates
* Implement a numbering system to your SOPs, forms and templates
* A complete Master Listing of all SOPs, forms, and templates
* An electronic package with the entire QMS program documentation (fully approved SOPs)
GMP and Quality Training to ensure all client’s personnel are well-trained and acquired good understanding on cGMPs:
* Prepare a comprehensive GMP training class presentation
* Provide in-person full GMP training for all facility employees
* Trainees will be provided with a cGMP test to confirm their understanding of the cGMP concepts learned in class
Additional Central Services:
* Implementation of the fully developed SOPs
* Implementation of the created forms to start generating GMP records
* Visits to the manufacturing facility as needed
Develop SQF Food Safety Program
Review the latest SQF Code and document the necessary and applicable guidelines in your operations.
Document all systems, work operations, and policies of your processes.
