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Packaging Specification Manager for Life Sciences


Packaging Specification Manager for Life Sciences

Packaging defects still account for the largest proportion of quality deficiencies in medicinal products. In fact the FDA Act mandates the need for adequate information related to packaging materials. 

Section 501(a)(3) of the Act states that a drug is deemed to be adulterated, if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.

The FDA requirements for tamper-resistant closures are stated in 21 CFR 211.132 and the Consumer Product Safety Commission (CPSC) requirements for child-resistant closures are included in 16 CFR 1700.

Non-compliance in strict adherence to packaging specifications as per cGMP norms would result in possible microbial contamination of the drug, compromised integrity of the efficacy of the drug or the worst case, compromised safety of the patient. 

The responsibilities of departments are divided across the real-estate of the package – be it primary, secondary, or tertiary. As a result, the designer and packaging engineer receive inputs from concerned departments in the form of word docs, emails, and spreadsheets. The room for the engineer or the designer to commit errors is very high. 

These errors would result in men, money, and months spent to attend to litigations, substantial fines, expensive damage to the brand’s reputation and ultimately it’s bottom lines. 

The Specification Manager helps teams from packaging, quality, supply chain, CMOs and CPOs achieve compliance to these norms by substantially reducing possibilities of human error.

Features:

  • Create Specifications

The Specification Management module provides a data form for every type of packaging component. Depending on the type of component the data fields can change. Create Specifications in line with your organizational templates. Bid adieu to multiple documents and spreadsheets and keep all your data in one place.

  • Share Specifications 

Specifications can be shared to multiple printers / CMOs / CPOs. Customers / Suppliers / Partners can also use the system to collaboratively build the specification.  Share specifications with internal and external stakeholders securely. 

  • Reuse Specifications 

Reuse existing specifications instead of creating separate specifications from the ground up. Instead of building a new specification for a component requirement, users are encouraged to re-use specifications so that cost-savings can be made. Users can search the specification database in ManageArtworks using numerous parameters to narrow down on the type of specification they want to use for the new component. So instead of creating a new specification, a closely matching existing specification can be used. 

A where-used search can be made for a specification sheet. Knowing which artwork components will need to change based on a specification change is essential. 

  • Manage Versions and Revisions

Each specification sheet can be sent for approval and version controlled. The specification sheet becomes effective once approved and can be published as a PDF file into the asset library. Automatic version & revision control to ensure ease in identifying obsolete and effective specifications

  • Flexible Specification Approval Workflow Process

The specification module integrates into the artwork process and it’s possible to link a specification sheet to a component in the artwork workflow. Map your own process or use standard templates for specification approval. 

Key Benefits

  • Reduce your time-to-market

With the Specification Manager, all your stakeholders will be on the same page enabling quicker approval times and enhanced visibility.

  • Effective Data Management

Ability to regulate data with mandatory and optional fields. Effective data management from one central source which helps you eliminate room for errors.

Incorrect packaging specifications can lead to costs of recalling and destroying the stock or worse, incur an irreparable loss to the brand’s reputation owing to widespread contamination from faulty packing.

Having access to consistent, correct, and complete packaging material specifications and descriptions are a prime guarantor of success.

Have our experts reach out to you and demonstrate how.

 

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