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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 2

 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 3

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. 4

5 Food and Drug Administration  Formed in 1906

 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. 6

 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. 7

 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.  Assay and identity specifications using a well characterized reference standard and description of physical characteristics are required. 8

 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. 9

 To submitting documents for packaging for human drugs and biological, the followings are required….  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. 10

 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. 11

 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. 12

 Exemption of a certain drugs from certain 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. 13

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. 14

 Uniformity of dosage units  Rate of release of the active ingredient from the dosage form by methodology (e.g:- dissolution rate), as appropriate for the dosage form.  Moisture content, where applicable. special consideration should be given to dosage forms in which a major component is known to be hygroscopic.  Softening or melting points for suppositories. 15

 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. 16

 Assay of preservative and pH determination.  Sterility where required.  Homogeneity.  Uniformity of dosage units as appropriate. 17

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 Pharmaceutical packaging technology—D A Dean E R Evans I H Hall 1 st ed.  Remington-- The science and practice of pharmacy, 21 st 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, 4 th ed. 19

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