PACKAGING AND LABELLING CONTROL ACCORDING TO GLOBAL GMP

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About Authors:
*Tarun Patel, Prof. Dr. Vipin Kukkar, Krunal Parik
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*tarunpatel35@gmail.com

ABSTRACT:
In pharma industry Packaging and Labelling plays very important role for improvements of attraction to human beings. So by improving our packaging and labeling style we can easily improve our product market value. Green packaging is also an alternative to make packaging more environmental friendly which would not affect the nature in any way. The most desirable solution is “use less, discard less, save more, reuse more”In this review article we discuss briefly about the requirement of packaging and labeling control of product according to different GMPs.

Reference Id: PHARMATUTOR-ART-1510

INRODUCTION
The pharma packaging industry in India is still n a nascent stage. “First impression is the last impression; packaging plays a very important role in creation that impression for any product. But when it comes to pharmaceuticals, it has to go beyond looks”. (Trend in pharma packaging, the pharma review, abstracted by international pharmaceutical abstracts and chemical abstracts) The way you package and label your product is important. First, packaging protects it from physical, chemical and microbiological invasion. The package also provides a medium for presenting advertising messages and other important information to the consumer. And finally, the package is one of the greatest influences on a consumer’s decision to try your product.

Packaging is a combination of science, art and technology. Considering the growing demand of packaging in the consumer market, it is observed that most of the consumer products manufacturing companies are demanding packaging professionals for procuring consistent qualitative packaging materials in optimum cost. In addition, it is also observed that the purchase and marketing departments various companies who deal with the packaging material require packaging experts. However, experts maintain that while investing and innovation in packaging, some key hallmarks have to be taken care of.

Packaging also makes a bridge between production and marketing. The thumb rule is applicable to pharmaceuticals as much any other product because packaging of drugs needs to convey that feel good factor to a patient who needs that drug to be cured. However, packaging is also used to disseminate important information regarding the drug like its contents or chemical formula, usage, storage, dosage, precautions related the drug usage, dates of manufacturing and expiry, batch number etc.(Trend in pharma packaging, the pharma review, abstracted by international pharmaceutical abstracts and chemical abstracts)

GENERAL GUIDELINES
Ideally, the samples should be taken from trial batches. Samples should be assembled in complete packaging materials. These studies should be made by storage testing. These studies will indicate effect of packaging material on the product & effect of product on the immediate packaging material, if the product & packaging material is finally decided. If not compatible, other packaging materials are tried.

After the final decision on packaging material has been taken, the product is subjected to shelf life studies to find out the loss of volatile material from the product, perfume y smelling & volatile material by weighing.

Finally other tests performed- in-use tests as well as laboratory tests like pour ability test, viscosity softening point, color, pH etc.

The FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics, addresses the review and evaluation of packaging requirements. According to this document, each New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) should contain enough information to demonstrate that a proposed container closure system and its componentsare suitable for its intended use.

The type and extent of information required will depend on the dosage form and route of administration. Qualification and quality review is applied to packaging materials and to the actual dosage form. Packaging suitability is based on four attributes: protection, safety, compatibility and performance (function and/or drug delivery). For inject able dosage forms, the document outlines the tests required to show that interaction is not a problem. Associated components, such as those used only at the time a dosage is administered, self-adhesive labels and secondary packaging materials are also included in the review process.
Inhalation and injection drug products have the highest requirements. There are product-specific draft guidelines for Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI), nasal sprays and inhalation solutions, suspensions and spray drug products. The identity and concentration of leachables in inhalation and nasal drug products must be monitored throughout the dosage form's shelf life, since the product consists of the dosage form and container closure system.

Extractable and Leachable in Primary Container/Closures Systems as well as other packaging components have the potential to interact with the dosage form. Factors that must be considered in evaluating container closure systems are: materials of construction of the container/closure system, surface treatments and/or processing aids, dosage form active ingredient and excipients, sterilization and/ or other related processing and storage conditions.
The presence of extractable is determined through artificial means. An extractable is a chemical species that can be released from a container or closure material of construction that has the potential for contaminating the dosage form. Under certain exaggerated solvent, temperature and time conditions, an extractable may be generated through an interaction with the closure system.

Extractable testing studies are recommended even if containers or closures meet compendial suitability tests. Extensive testing for extractables should be performed as part of the qualification of the container/closure components. Testing under stressed conditions should demonstrate that the extractable profile is acceptable for the specific dosage form and that levels observed will not be approached or exceeded during the shelf life of the drug product.
A leachable is a chemical species that has migrated from packaging or other components into the dosage form under normal conditions of use or during stability studies. Leachables are substances identified in a defined laboratory regimen by simulating use conditions. The industry is focused on potential problems associated with extraction of chemicals from packaging materials into drug product. Leachables are a subset of extractables.(Sharma P.P.)

REGULATIONS IN PHARMA PACKAGING
In India there are two major government agencies responsible for drug regulation and control:
1.      The drug controller general of India (DCGI)
2.      The state food and drug a dministrations (FDAs)

The guidelines divides the parenteral (glass or plastic) and non-parentral (glass, plastic or metal) along with pressurized containers and bulk containers. Closures and liners are also given prominence.

The FDA does not approve containers as such, but only the materials used in the container. A list of substances considered “generally recognized as sage” (GRAS) has been published by the FDA. In the opinion of qualified experts they are safe under specified conditions, assuming they are of good commercial quality.

A material that is not included under FRAS or prior sanction, and is intended to be used with food, must be tested by the manufacturer, and the data must be submitted to the FDA.

The FDA has published regulations (part 133) that implement the current good manufacturing practice requirements of section 501(a) of the act Numerous guidance (see Table A below) mention the appropriate evaluation of packaging components. This guidance recommends that the safety and compatibility of the dosage form with the primary container closure system be established early in the development process. Specific focus is on the potential for drug/biologic interaction with the container or closure because of leaching or absorption.(Jenkins A. Wilmer)

Table 1: Guidances for Packaging Components

CPMP:

Note for Guidance on Development Pharmaceutics (1998)

CPMP:

Development Pharmaceutics for Biotechnological and Biological Products, Annex to Note for Guidance on Development Pharmaceutics (1999)

ICH Q6A:

Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (2000)

ICH:

The Common Technical Document for the Registration of Pharmaceuticals for Human Use, Quality (Draft, 2000)

Industry- based working groups have been established to assess extractable concerns and other scientific issues. The Product Quality Research Institute (PQRI) was established to conduct research that generates scientific information to support the development of regulatory policy. PQRI is driven by its member organizations which include (but are not limited to) the American Association of Pharmaceutical Scientists (AAPS), the Pharmaceutical Research and Manufacturers Association (PhRMA), the Generic Pharmaceutical Association (GPhA), the Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration Center for Drug Evaluation and Research (FDA/CDER). PQRI is a nonprofit foundation that serves as a vehicle for FDA, industry and academia to collaborate on key issues in pharmaceutical product quality through research and expert analysis. Currently, PQRI's working group for leachables and extractables is attempting to better define and clarify analytical and toxicological issues relating to these key areas.

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