cGMP Quality Assurance, FDA Approved DMF, & Canadian Drug Master Files

cGMP Quality Assurance - Pharmaceutical companies emphasize quality in all aspects of their operations and extend that philosophy to include their suppliers.  The expectation is that the supplier will perform to the same level of quality the pharmaceutical company demands of itself.  This is especially important for a supplier of critical primary packaging components.  Failure of these components may lead to compromising the quality of the drug product.

 

Recognizing that quality begins before the packaging components ever reach their plant, pharmaceutical companies expend considerable resources to qualify a supplier before conducting business with them.  This qualification process assesses the effectiveness of the supplier's quality assurance system to ensure that the supplier:

 

 

  • Meets the requirements of cGMP (see below)

  • Has appropriate standards, procedures, policies, and controls in place

  • Complies with and maintains the quality system, such as appropriate training of personnel

Even after this extensive qualification process, pharmaceutical companies periodically conduct supplier audits on key aspects of the supplier's quality processes to ensure these quality systems are adhered to.  Pharmaceutical companies prefer to do business with like-minded suppliers.  The partnership that develops ultimately results in packaging that meets the demanding standards of the industry.

Current Good Manufacturing Practice (cGMP) - All aspects of Winpak Control Group's operations are governed by our commitment to assist our customers to fully comply with FDA cGMP regulations.  Our commitment supports customers in meeting their required obligation with the FDA and benefits other companies, even those not regulated by the FDA.  The "c" for "current" in cGMP reminds manufacturers that they must employ technologies and systems that are up-to-date in order to comply with the regulation.

Promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act, GMP regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, and some food products must take proactive steps to ensure that their products are safe, pure, and effective.  GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.  This in turn protects the consumer from purchasing a product that is not effective or even dangerous.

GMP Regulations address all areas of our business operations including record keeping, personnel qualifications, sanitation, cleanliness, equipment and process validation, and complaint handling.  Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls.  This provides flexibility, but also requires that the manufacturer interpret the requirements in a manner that makes sense for each individual business.

US FDA & Canadian Approved Drug Master Files
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) and the Canadian Therapeutic Products Directorate that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.  Law or FDA regulation does not require the submission of a DMF.  A DMF is submitted solely at the discretion of the holder.  The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), another DMF, an Export Application, or amendments and supplements to any of these.

 

 

A Type III Drug Master File (DMF) was accepted by the USA FDA & the Canadian Therapeutic Products Directorate as prepared and submitted by Winpak Control Group.  This DMF was created to support our position within the pharmaceutical industry as a provider of flexible packaging components critical to the drug manufacturer's package.

Investments in new equipment and our commitment to Research & Development have enabled us to develop and manufacture our own flexible packaging structures.

These structures are reverse printed and are a combination of extrusion and adhesive laminated multilayer structures comprised of:

  • Type I: Manufacturing site, facilities, operating procedures, and personnel (no longer applicable)

  • Type II: Drug susbtance, drug substance intermediate, and material used in their preparation, or drug product

  • Type III: Packaging material

  • Type IV: Excipient, colorant, flavor, essence, or material used in their preparation

  • Type V: FDA-accepted reference information

 

 

  • PET: Polyester-various thicknesses

  • Foil: .000285 - .00035

  • Sealant: EAA, Surlyn, LDPE, & LLDPE in various thicknesses

Our customers now have access to our proprietary information. This information is available via the DMF process created by the US FDA and the Canadian Therapeutic Products Directorate.

Specifications

Quality Audit Options

Canadian Therapeutic Products Directorate File # 2008-079
cGMP
GMP
QA Audit
USA FDA Drug Master File (DMF #20000)

DMF Types

Type I: Manufacturing site, facilities, operating procedures, and personnel (no longer applicable)
Type II: Drug substance, drug substance intermediate, and material used in their preparation, or drug product
Type III: Packaging material
Type IV: Excipient, colorant, flavor, essence, or material used in their preparation
Type V: FDA accepted reference information

Industries Served

Pharmaceutical

©2019 Winpak Control Group Inc.

 

Winpak Control Group

500 Walnut Street

Norwood, NJ 07648

 

Phone: 201.784.8721

Fax: 201.784.1527

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For more information on our parent company, please visit Winpak Ltd.

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