PACKAGING AND LABELLING CONTROL BY AMIT

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Packaging & Labeling Control:

Packaging & Labeling Control Prepared by:- Amit Mavani Guided by:- Mr.Vijendra Chauhan Mrs.Riddhi Madhu Mr.Suman Acharya M.V.B.M.C.P. Dumiyani . 2/20/2012 1

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AN INTRODUCTION TO PHARMACEUTICAL PACKAGING Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation, and production of packages. Packaging contains, protects, preserves, transports, informs, and sells. It is fully integrated into government, business, institutional, industry, and personal use. 1.1 The Pack A simple definition of a pack is: A pack is the economical means of providing for a product • Presentation • Protection • Identification/information • Convenience/containment/compliance Until such time as the product is used or administered, paying due attention to any relevant environmental issues. 2/20/2012 2

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The term ‘pack’ in the above covers all the components involved, i.e. the primary or immediate pack, which consists of those materials in direct contact with the product. The secondary pack and sometimes tertiary components enable the product to be stored, transported and displayed, and possibly assist use. Tertiary components may include ancillary components e.g. leaflets or inserts, separate dispensing spoons and measures. 2/20/2012 3

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Qualities of the Package For any packaging material basic 5 qualities are required. 1)Protection Must protect against all adverse external influences that may affect quality, such as light, moisture, oxygen, mechanical damage . Some aspects of protection are superficial, such as the wrapping of an outer carton in cellulose film to avoid dust, but the protection given to the product by the primary package is very important. 2}Identification The package must also give clear identification of the product at all stages and, again, the life of the patient may depend upon rapid and correct identification in emergencies. Often, the package is required to identify the manufacturer to the user by a characteristic house style. 2/20/2012 4

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3 }Presentation:- Good presentation enhances the product and attracts the consumer during storage or display. In addition, the public can judge the product only by the appearance of the package, so that a dignified and professional presentation will give confidence to the user. 4 }Convenience:- The form of package should be such that it offers convenience at all stages of its life history and the design of the package should be convenient for manufacturer, for transport and storage and for the use by consumer. 5 }Economic:- The economics of packaging are considerable practical importance; the package cost should be minimal, provided the previous qualities are not prejudiced. In particular, care should be taken to ensure that protection is not sacrificed simply to reduce package costs. 2/20/2012 5

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Package Material Properties :- Mechanical properties The materials must give the container sufficient mechanical strength to withstand handling empty, when filling, and when closing (all these are often performed mechanically); processing (labeling, sterilization, etc.), transports, storage and supply to, and use by, the consumer. Typical of the care in design needed in this respect are glass containers. 2/20/2012 6

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Physical properties:- The container must be able to withstand heat if the processing includes the sterilization. The surface must be capable of clear labeling, often difficult, for e.g., with plastics. The material must protect from light, if necessary it must be ultra violet absorbent. The container must not attract substances from product; e.g., absorption of water from creams into cardboard boxes. 2/20/2012 7

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Chemical properties:- The container and closure should not react together, either alone or in the presence of the product. The product should not react with the containers or closures, as might happen if alkaline substances are packed in aluminum containers. Substances must not be abstracted from the product, such as the loss of bactericides from injection solutions to rubber. The containers or closures must not yield substances to the product; for example, alkali from glass or plasticizer from plastics. 2/20/2012 8

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Biological properties :- The materials of the containers must be able to protect the attack by the insect if this hazard is likely to be encountered. The package should not support the mould growth. 2/20/2012 9

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2/20/2012 10 Packaging Materials Metals Metal containers are used mainly for dry products, due to the effect of trace metal contamination introduced by the corrosion, especially of iron. Aluminum containers and collapsible tubes for creams and ointments. Metal foils, especially aluminum are used for sachets and unit pack of tablets. Plastics Coming into increasing use are Phenol, urea, melamine- formamide resin as screw closure. Polystyrene tubes for tablets Polyethylene is widely used for flexible containers, closures, bags, etc. Polypropylene is similar to polyethylene but it has greater transparency and better heat resistance. It is also more resistant to attack by solvent, but more expensive than polyethylene. Cellulose acetate is used as films for unit packs of tablets in the same way as foils, but it has lower strength and moisture resistance.

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2/20/2012 11 Paper and board Papers and boards have a variety or uses for external packages, but used for the primary packs is limited; usually impregnated, for e.g. with wax or plastics. Glass Type I glass (commonly known as neutral glass) offers a high hydrolytic resistance due to chemical composition of the glass. Type II glass has a high hydrolytic resistance due to an appropriate surface treatment. Both types of glass may be used for different types of injectable preparations. Type III glass offers only a moderate hydrolytic resistance and should be used only for non-aqueous liquid preparations or for powders for injection or for injectable preparation where adequate suitability tests have indicated that this type of glass is satisfactory or for preparations not for parenteral use. Containers of Type II or Type III glass should be used once only. Glass may have additives to absorb light particularly ultraviolet. Rubber It is needed in a specialized form for closure for injection containers .

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The Purposes of Packaging:- Packaging and package labeling have several objectives. Physical protection The objects enclosed in the package may require protection from, among other things, shock, vibration, compression, temperature, etc. Barrier protection A barrier from oxygen, water vapor, dust, etc., is often required. Keeping the contents clean, fresh, sterile and safe for the intended shelf life is a primary function. Containment or agglomeration Small objects are typically grouped together in one package for reasons of efficiency. For example, a single strip of 10 tablets requires less physical handling than 10 tablets. 2/20/2012 12

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Information transmission:- Packages and labels communicate how to use, transport, recycle, or dispose of the package or product. Marketing The packaging and labels can be used by marketers to encourage potential buyers to purchase the product. Security R educing the security risks of shipment. Packages can be made with improved tamper resistance. Convenience Packages can have features which add convenience in distribution, handling, stacking, display, sale, opening, reclosing, use, and reuse. 2/20/2012 13

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Packaging instructions :- Following instruction: (a) the name of the product; (b) a description of its pharmaceutical form, strength and, , method of application; (c) the pack size , weight or volume of the product in the final container; (d) a complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types, with the reference number relating to the specifications for each packaging material; 2/20/2012 14

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(e) where the batch number and expiry date of the product have been marked; (f) special precautions . (g) a description of the packaging operation, including any significant subsidiary operations, and equipment to be used; (h) details of in-process controls with instructions for sampling and acceptance limits. 2/20/2012 15

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Labelling :- Labels applied to containers, equipment or premises should be clear. It is often helpful in addition to the wording on the labels to use colours to indicate status (e.g. quarantined, accepted, rejected, clean). (a) the name of the drug product; (b) a list of the active ingredients , showing the amount of each present and a statement of the net contents (e.g. number of dosage units, weight, volume); e.g:pcm 500 mg (c) the batch number assigned by the manufacturer; (d) the expiry date (e) special storage condition. (f) directions for use, and warnings and precautions that may be necessary; (g) the name and address of the manufacturer or the company . 2/20/2012 17

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Labeling issuance:- a. Strict control shall be exercised over labelling issued for use in drug product labelling Operations. b. All excess labeling bearing control numbers shall be destroyed. c. Procedures in sufficient detail shall be employed for the issuance of labeling. III. Packaging and labeling operations: Identification need not be applied to each individual container. b. Identification of the drug product with a control number that permit history of Manufacture. 2/20/2012 19

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c. Inspection of the packaging and labeling facilities immediately before use to assure that all drug products have been removed from previous operation. Tamper-evident packaging requirements for OTC human drug products : A tamper-evident package may involve an immediate container and closure system to Provide a visual indication of package integrity. b. In addition to the tamper-evident packaging feature hard gelatin capsule covered by this section must be sealed using an acceptable tamper-evident technology. Expiration dating: a. Expiration dates shall appear on labeling in accordance with the requirements. b. Homeopathic drug products shall be exempt from the requirements. 2/20/2012 20

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Line clearance:- The term line clearance is used for the documented act of conducting any necessary removal of products and materials from a manufacturing line to prepare the line for the next production(packaging). A line clearance procedure is having three stages Clearing:- Remove the previous product related items from the area/line i.e. pre printed ampoules , plugs , left over solution/material , product , labels , printed cartons. Cleaning:- Cleaning to be carried out only after clearing of previous products. Clean the as per current SOP. Checking:-  Checking to be carried out only after clearing and cleaning of previous products. 2/20/2012 21

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Reconciliation of labels: It is a method and means for reconciliation between faulty labels identified during a labeling operation and removed from the operation. It is plays an imp role during label issuance. It is an important to reconcile all the packaging material; especially the over printed packing materials like labels,cartons and wrappers because it leads to misuse and product mix-ups if not accounted. 2/20/2012 22

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Procedure:- On the completion of packing of particular batch determine the Quality of labels used Quality of labels rejected. Labels used for quality control for testing, for control samples. Quality used for relabeling and balance labels. This totally reconcile quantity is compared with the intended quantity. Note the variance and destroy all the balance and rejected labels under proper supervision. B) Boxes, cartons, wrappers At the end of packing operation, determine the number of boxes, cartons, wrappers used. To this add the quality taken by the quality control for checking, for control samples, rejection online due to defects and the balance quantity of the packaging. Calculate and note the variance, the rejected and balance packing material should be destroyed Under proper super vision. 2/20/2012 23

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REFERENCES Quality assurance of pharmaceuticals volume 2 Good manufacturing practices for pharmaceuticals , Sidney H. willig & James R. stoker ,fifth edition,page no:139-172 Available on www.who.int 2/20/2012 24

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THANK YOU 2/20/2012 25