Certification
By engaging the expertise of scientists trained in quality control & good manufacturing practices and others with regulatory and pharmacology/toxicology/environmental specialties ASER has created a Quality Assurance (QA) & GMP (Good Manufacturing Practices) program. This new and independent certification process helps industry's clients and consumers identify them as companies who are invested in and committed to producing and marketing Quality Products.
Certification granted to a product manufacturer and/or distributor will signify that the products labeling conforms to the current federal laws and regulations applicable to the dietary supplements. The product may only be considered safe based on studies and/or prior human experiences, (See Science Data Seal) and if it is manufactured according to the current GMP as applied in the industry.
The Certification will expire in one year unless renewed by the certified manufacturer. Each years renewal review will be based on review of any label changes, results of random sample analysis, and adherence to Good Manufacturing Practices.By engaging the expertise of scientists trained in quality control & good manufacturing practices and others with regulatory and pharmacology/toxicology/environmental specialties ASER has created a Quality Assurance (QA) & GMP (Good Manufacturing Practices) program. This new and independent certification process helps industry's clients and consumers identify them as companies who are invested in and committed to producing and marketing Quality Products.
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ASER Certification Process |
Manufacturers (or importers, distributors) will submit relevant data in the areas of Pharmacology, Clinical Data, GMP and Labeling, to support the certification of the product
Each Dietary Supplement that displays the ASER QA Seal must not only pass the product certification process, but must also have the manufacturer of the product prove that it is capable of producing each bottle consistently, batch-to-batch, without error or contamination and in compliance with current Good Manufacturing Practices (GMPs).
The Manufacturer must assure that the product ingredients meet safety / regulatory requirements. In addition, the manufacturer must demonstrate that each ingredient is of high quality and purity. Below are some GMP requirements.
Good Manufacturing Practice in Manufacturing, Packing, or holding Dietary Supplements:
Labeling:
a). Administration and dosage
b). Appropriateness of claims
c). Adequacy of warnings and/or cautions
Certification Addresses:
Manufacturing Issues:
Regulatory Issues:
This ASER Seal when displayed on a product recognizes the validation of a product manufacturers research related to the product displaying the seal. For the Science Data Seal, the manufacturer must provide two or more peer-reviewed clinical studies, along with the publication and data. The studies must find that the product was both safe and effective for the intended use. In addition, this seal validates that the manufacturer had certified to ASER that they comply with GMP as outlined by the USFDA, and provided documentation to ASER that the supplement is manufactured under these Good Manufacturing Practices.
CRITERIA FOR THE ASER SCIENCE-DATA SEAL
(QUALITY ASSURANCE PRODUCT CERTIFICATION * MANUFACTURING * SCIENCE - DATA )
1. Clinical Research & Publication of Data Proving Efficacy & Safety: Finished Products will need to have at least two randomized, clinical trials. (double-blind placebo controlled is preferred, but not specifically required) Data must be published in peer-reviewed journals Data must show there is statistical efficacious significance over placebo Data must confirm safety
2. Manufacturing GMP and Product Safety:
Validation of FDA Compliant Good Manufacturing Practice.
Verification of suppliers - Verification of the validity and quality of the product ingredients.
Product ingredients must meet safety and regulatory requirements including purity.
Batch to batch consistency of the product.
QA/QC Program in place with Batch to batch consistency of the product.
Label Compliance: (Label conforms to Federal regulations including dosage.
recommendations, adequacy of any warnings and or cautions and appropriate claims applicable to dietary supplements).
Quality Control and Laboratory operations.
Production and process controls.
GMP Compliant Warehouse and distribution procedures.
Stability and Standardization testing of the supplement.
In the ASER Organic Certification, we post the findings from our inspection and analysis of each site/field. This evidence demonstrates to the end user/customer when the Company has been inspected, the results, and any other information from the company that validates their Organic SOP.
The Certificate of Free Sale certifies that the specified goods are normally and freely sold in the issuing country's open markets and are approved for export.
When a product is entering a new market, the identity in its origin country is usually asked, especially for products that potentially pose concerns on consumer health and safety.Certificate of Free sale assures that the product is unrestricted for sale in the home country and local markets and complies with every applicable government regulation in terms of safety, labeling and point-of-sale packaging requirements.
For this reason, the ASER Certificate of Free Sale is not only a historical report of the products compliance in its home market(s), and useful for exporting purposes, but also helps with consumer confidence toward the certified goods.
(HEALTH & BEAUTY PRODUCT QUALITY ASSURANCE PRODUCT CERTIFICATION)
1. Clinical Research & Publication of Data Proving Efficacy & Safety: Finished Products will need to have a review of all product ingredients, have science based data/historical evidence to support any Health and/or Beauty claims.
2. Manufacturing GMP and Product Safety:
Validation of Compliant Good Manufacturing Practice.
Verification of suppliers - Verification of the validity and quality of the product ingredients.
Product ingredients must meet safety and regulatory requirements including purity.
Batch to batch consistency of the product.
QA/QC Program in place with Batch to batch consistency of the product.
Label Compliance: (Label conforms to Federal regulations including dosage.
recommendations, adequacy of any warnings and or cautions and appropriate claims applicable to dietary supplements).
Quality Control and Laboratory operations.
Production and process controls.
Stability and Standardization testing of the supplement.
(NATURAL & QUALITY ASSURANCE PRODUCT CERTIFICATION)
1. Clinical Research & Publication of Data Proving Efficacy & Safety: Finished Products will need to have a review of all product ingredients, to assure that 70% of the finished product is made up of non-synthetic ingredients.
2. Manufacturing GMP and Product Safety:
Validation of Compliant Good Manufacturing Practice.
Verification of suppliers - Verification of the validity and quality of the product ingredients.
Product ingredients must meet safety and regulatory requirements including purity.
Batch to batch consistency of the product.
QA/QC Program in place with Batch to batch consistency of the product.
Label Compliance: (Label conforms to Federal regulations including dosage.
recommendations, adequacy of any warnings and or cautions and appropriate claims applicable to dietary supplements).
Quality Control and Laboratory operations.
Production and process controls.
Stability and Standardization testing of the supplement.
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