Transcript REGULATORY REQUIREMENTS FOR PACKAGING

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It is defined in the regulations as “all products made of
any materials of any nature to be used for the
containment, protection, handling, delivery &
preservation of goods from the producer to the user or
consumer.
 OBJECTIVES OF PACKAGING:Physical protection
Barrier protection
Containment or agglome
Security
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A pack has a number of functions to perform during its
life, including storage, carriage, display, sale, use etc..all
of which require in-depth consideration.
 A simple definition of a pack is: a pack is the
“economically” means of providing for a product
• Presentation
• Protection
• Identification/Information
• Convenience/Containment/Compliance
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S ----Shock
C ----Compression
R ----rattle(vibration)
A ----abrasion
P ----puncture
C ----containment/compatability between pack & product
A ----ageing(certain combinations involving several sources
R ----rodents or similar animal sources of contamination
T ----theft
M ----moisture( relative humidity(RH) rain, sea water)
I ----insects
S ----sunlight or any other light sources
T ----temperature(extremes)
M ----microbiological
A ----atmospheric— gases,dust,dirt,oxygen,carbon dioxide,pressure
differences
R ----recycling/recovery/reduce
D ----disposal—indirect hazards associated with ultimate disposal of pack
–product including any pollution risks.
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Food and Drug Administration
Formed in 1906
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 FDA plays a major role in the approval of
manufacturing materials used in packaging
materials and also publishes the list of materials
which are generally considered as safe (GRAS).
 According to WHO guidelines the packaging
material must satisfy the following points:
 protect against all adverse external influences that
can alter the properties of the product, e.g.
moisture, light, oxygen and temperature variations;
 protect against biological contamination;
 protect against physical damage;
 Carry the correct information and identification of
the product.
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Regulatory specifications are the defined limits(e.g:physical, chemical, biological, micro biological) within
which test results for a substance or drug product.
 The regulatory tests and specifications should be
designed to ensure that the dosage will meet
acceptable therapeutic & physiochemical standards
through out the shelf life of the marketed product.
 Regulatory specifications includes all criteria that apply
to the bulk dosage form, those related to the packaged
product, & those that indicate the presence or absence
of degradation.
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When alternative analytical methods that are equivalent
to, or that are an improvement over, the compendial(IP
methods) are submitted to the agency, the applicant is
encouraged to simultaneously ask the (USPC) to change
or modify the methodology in the monograph.
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Assay and identity specifications using a well
characterized reference standard and description of
physical characteristics are required.
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 It defines the type of containers to be used,
dividing them in to parentral or non parentral
containers, pressurized containers and bulk
containers for active ingredients and drug
products.
 The packaging components are discussed for
physical, chemical and biological specifications,
characteristics and tests to be applied, stability
and compatability.
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 To submitting documents for packaging for
human drugs and biological, the followings are
required….
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Package must maintain standards, identity, strength,
quality and purity of drug for intended shelf life.
Full information needed.
Type of container or closure.
Suitable for intended use.
Submission of packaging information and date.
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 Along with original form of any drug following
information are to be supplied….
 DESCRIPTION –General description of container
with closure :name, product code, physical
description, manufacturer, raw material, any
additional treatment.
 SUITABILITY-Protection against light, oxygen,
moisture, leakage, microbes, dirt etc….
 STABILITY-Expiry of pharmaceutical product or
formulation.
 PERFORMANCE-Consistency in composition.
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 Under the provisions of the federal food, drug and
cosmetic act 1940, it is of the manufacturer to
provide the safety of a packaging material and to
get approval before using it for any food and drug
products.
 FDA does not approve the containers as such but,
the materials used in the container .
 A list of substances considered “Generally
recognized as safe”,(GRAS) has been published by
FDA.
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 Exemption of a certain drugs from certain
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provisions of this part:Labels on packages or containers of the drug for
export shall be adapted to meet the specific
requirements of the law of country, the following
considerations to be followed
a)name of the drug
b)the name, address of the manufacturer, and the
number of the license under which the drug has
been manufactured.
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c)Batch or lot number.
d)Date of expiry, if any;
 Prohibition of sale or distribution unless
labeled:- Subject to the other provision of these
rules, no person shall sell or distribute any drug
including or patent or proprietary medicine unless
it is labeled in accordance with these rules.
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Uniformity of dosage units
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Rate of release of the active ingredient from the
dosage form by methodology (e.g:- dissolution rate), as
appropriate for the dosage form.
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Moisture content, where applicable. special
consideration should be given to dosage forms in which
a major component is known to be hygroscopic.
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Softening or melting points for suppositories.
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Clarity, limit of particulate matter, assay of preservative,
isotonicity(for injectable and ophthalmic products), and
pH determination.
 Sterility of injectable and ophthalmic products.
 Pyrogen test for injectable products.
 Leakage test for ampoules, aerosols, pouch packets,
strips, tubes, etc….
 Metering tests and specifications and container
pressure for aerosols.
 Completeness and clarity of constituted solutions.
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 Assay of preservative and pH determination.
 Sterility where required.
 Homogeneity.
 Uniformity of dosage units as appropriate.
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 Pharmaceutical packaging technology—D A Dean
E R Evans I H Hall 1st ed.
 Remington-- The science and practice of
pharmacy, 21st ed.
 Pharmaceutical packaging Technology –U K Jain, D
C Goupale, S Nayak.
 FDA Regulatory Affairs –Douglas J.Pisano, David
S.Mantus.
 Leon Lachman, Lieberman AH, Kanig JL—The
theory and practice of Industrial pharmacy, 4th ed.
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