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Our Contract Manufacturing Facility’s
GMP Certifications
What are GMPs?
Good Manufacturing Practices (GMPs) are
guidelines that provide a system of processes, procedures, and documentation to
assure that the product produced has the identity, strength, composition,
quality, and purity that it is represented to possess. Certification audits
include inspections of personnel, plant and grounds, sanitation, equipment,
quality operations, production and process controls, and warehouse,
distribution, and post-distribution practices. (See below, Areas of the
Manufacturing Process Governed by GMPs, for more detailed information.)
NPA GMP Certification
This certification is issued by the NPA (Natural Products
Association; formerly called the National Nutritional Foods Association) only to
those companies that have met certain requirements, which are verified through a
third-party auditing program. The third-party auditor must award an "A" rating
to a company before they can receive the NPA GMP Certification. This
certification represents one of the highest standards of quality in the
industry.
NSF International GMP
Certification
NSF International (formerly National Sanitation Foundation)
is a not-for-profit, non-governmental organization that develops standards, and
provides product certification and education in the field of public health and
safety. The NSF Good Manufacturing Practices (GMP) Registration for contract
manufacturers and internal manufacturing facilities of dietary supplement
companies enables contract manufacturers to become independently registered by
NSF as complying with GMP requirements as listed in Section 8 of NSF/ANSI
Standard 173-2006.
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Areas of the Manufacturing
Process Governed by GMPs
ORGANIZATION AND PERSONNEL
Responsibilities of quality control unit
Personnel qualifications
Personnel responsibilities
Consultants
BUILDINGS AND FACILITIES
Design and construction features
Lighting
Ventilation, air filtration, air heating and cooling
Plumbing
Sewage and refuse
Washing and toilet facilities
Sanitation
Maintenance
EQUIPMENT
Equipment design, size, and location
Equipment construction
Equipment cleaning and maintenance
Automatic, mechanical, and electronic equipment
Filters
CONTROL OF COMPONENTS AND PRODUCT CONTAINERS AND CLOSURES
General requirements
Receipt and storage of untested components, product containers, and closures
Testing and approval or rejection of components, product containers, and
closures
Use of approved components, product containers, and closures
Retesting of approved components, product containers and closures
Rejected components, product containers, and closures
PRODUCTION AND PROCESS CONTROLS
Written procedures; deviations
Charge-in of components
Calculation of yield
Equipment identification
Sampling and testing of in-process materials and products
Time limitations on production
Control of microbiological contamination
Reprocessing
PACKAGING AND LABELING CONTROL
Materials examination and usage criteria
Labeling issuance
Packaging and labeling operations
Tamper-evident packaging requirements
Product inspection
Expiration dating
HOLDING AND DISTRIBUTION
Warehousing procedures
Distribution procedures
LABORATORY CONTROLS
General requirements
Testing and release for distribution
Stability testing
Special testing requirements
Reserve samples
RECORDS AND REPORTS
General requirements
Equipment cleaning and use log
Component, product container, closure, and labeling records
Master production and control records
Batch production and control records
Production record review
Laboratory records
Distribution records
Complaint files
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