Packaging and labeling are important components of commercial and clinical products

[Adam Fleming]

Packaging and labeling of commercial and clinical products are very important aspects to an organization involved in a business that relates to these products. While the packaging and labeling of commercial products is important, it is more so with clinical products, because these products play an important role in a clinical trial and also in the very life of a patient or subject.

Commercial products have their own value over time. The FDA has guidances for commercial pharmaceutical products. Subpart G of CFR 21, Vol 4 concerns itself with packaging and labeling control. In line with its guidances on many related topics, this section deals with requirements for how labeling and packaging have to be carried out. These are some of the FDA’s rules on this topic:

o  Written procedures that describe how the labeling and packaging materials are received, identified, stored, handled, sampled, examined and tested and followed

o  Rejection of labeling and packaging materials that do not meet specifications or fail to meet their purpose

o  Maintenance of records of packaging and labeling for each shipment

o  Putting proper labels for each pharmaceutical product that describes the ingredients, strength, dosage and expiry date clearly

o  Destruction of expired products

o  Cancellation of license for pharmaceutical commercial products that fail to meet these requirements

The role of packaging and labeling in clinical trial products

Given the importance of clinical trials, and considering another equally important factor –namely that they are conducted across the globe these days –the need for extreme stringency in the packing and labeling of clinical trials products can never be overstated. In the area of clinical trials, these are the most popular packages:

o  Blisters

o  Bottles

o  Pouches

o  Syringes

o  Tubes

Irrespective of which of these packaging forms one is dealing with; there are stringent regulations for how to handle the packaging and labeling of clinical trials products. These regulations require manufacturers to maintain patient-friendly packaging and maintain strict standards concerning the following activities:

o  Filling of the product

o  Assembling it

o  Sorting it

o  Ensuring stability and containment of the product

Learn about the topic of packaging and labeling

All the nuances of packaging and labeling in the commercial and clinical products arena will be taught at a meaningful and educative webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, Peggy J. Berry, who is the President and CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development; will be the speaker. Please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501226L...

Teaching on all the key elements of packaging and labeling for commercial and clinical trial products

Peggy will introduce all the elements of packaging and labeling for commercial and clinical trial products at this webinar. The ways of transforming a protocol into an optimal package design will be one of the main constituents of this session. She will complete a review of the compliance requirements between commercial and clinical packaging and labeling, as well as a case study of changing commercial packaging for optimization.  

Key personnel in the pharmaceutical commercial and clinical trials areas, such as    manufacturing personnel, quality and compliance personnel, regulatory personnel and clinical operations, will gain immense insights into this subject at this webinar, since Peggy will discuss all the core and auxiliary topics of commercial and clinical trials packaging and labeling, such as

o  Laws and regulations related to packaging and labeling

o  Guidelines implemented during commercial and clinical packaging and labeling

o  Implementing SOPs to ensure compliance

o  Implementing appropriate change control procedures

o  Selection of materials for packaging and labeling

o  Required submission content for the IND/NDA related to packaging and labeling materials and procedures

o  Commercial packaging compliance

o  Commercial labeling compliance

o  Clinical packaging compliance

o  Clinical labeling compliance

o  Change control for materials, design and content

At this session, the speaker will cover the following areas:

o  Commercial packaging compliance

o  Commercial labeling compliance

o  Clinical packaging compliance

o  Clinical labeling compliance

o  Change control for materials, design and content)

o  Pharmaceutical (drug/biologic).

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