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Our Contract Manufacturer’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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