packaging Material GMP

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Presented by: Miss.Viral S. Patel. M.Pharm (1 ѕt sem) Roll no.:5 Guided by: Mr.Dharmendra A. Baria . Assistant professor Dept. of Pharmaceutical chemistry DHARMAJ DEGREE PHARMACY COLLEGE, DHARMAJ . PACKAGING AND LABELLING CONTROL

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Definition Types of packaging The purpose of packaging and package labels Packaging identification labelling of APIs and intermediates Label issuance and control Packaging and labelling operations Master batch packaging formula Temper evident packaging Child resistance packaging Line clearance Reconciliation of labels Cartons and other packaging materials CONTENT

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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. Labelling: Labelling or package labelling is any written, electronic or graphic communications on the packaging or on a separate but associated label. Packaging material: Any material, including printed material, employed in the packaging of a phar­maceutical, but excluding any outer packaging used for transportation or ship­ment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product. DEFINITIONS

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There are many types of packaging: Primary packaging: it is the material that first envelops the product and holds it. This is the smallest unit of distribution and it is in direct contact with contents. E.g. ampoules, vials, rubber plugs, bottles, foils, etc. Secondary packaging: it is outside the primary packaging and used to group primary packages together. E.g. cartons, labels, inserts Tertiary packaging: it is used for bulk handling, warehouse storage and transport shipping. E.g. external labels, gum tapes, etc. Types of packaging

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There are also classified in following categories: Printed packaging material: The materials which are printed. E.G. Foils, cartons, labels, etc. They need to be stored in more controlled conditions and need to be handled with extra care because these materials can become a source of mix-ups and misuse. Unprinted packaging material: All materials which are not printed when received from the suppliers.

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Physical protection: The objects enclosed in the package may require protection from , among other things, shock, vibrations , compression, temperature, etc. Barrier protection: A barrier from oxygen, water vapor, dust, etc ., is often required. Permeation is critical factor in design. Containment or Agglomeration: Small objects are typically grouped together in one package for reasons of efficiency. For example, a single box of 1000 capsule requires less physical handling than 1000 capsule single. Liquids, powders and granules need containment. The purpose of packaging and package labels

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Information transmission: Packages and labels communicate how to use, transport, recycle, or dispose of the package or product. Security: Packaging can play an important role in reducing the security risks of shipment . Packages can be made with improved tamper resistance to deter tampering and also can tamper-evident feature to help indicate tampering.

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Convenience: Packages can have feature which add convenience in distribution, handling, display, sale, opening, re-closing, use and reuse. Portion control: Single serving or single dosage packaging has a precise amount of contents to control usage. Bulk commodities can be divided into packages that are a more suitable size for individual households. It is also aids the control of inventory.

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Formally authorized packaging instructions should exist for each product, pack size and type . These should normally include, or make reference to: (A) The name of the product; (b) A description of its pharmaceutical form, strength and, where applicable, method of application; (c) The pack size expressed in terms of the number, weight or volume of the product in the final container; Packaging instructions

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(d) A complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types, with the code or reference number relating to the specifications for each packaging material; (e) Where appropriate, an example or reproduction of the relevant printed packaging materials and specimens, indicating where the batch number and expiry date of the product have been marked;

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(f) Special precautions to be observed, including a careful examination of the packaging area and equipment in order to ascertain the line clearance before and after packaging operations; (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.

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Label issuance and control Packaging and labelling operation Master batch packaging formula Packaging identification labelling of APIs and intermediates

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Access to the label storage areas should be limited to authorized personnel. Procedures should be used to reconcile the quantities of labels issued, and returned and to evaluate discrepancies found between the number of containers labelled and the number of labels issued. Such discrepancies should be investigated. Returned labels should be maintained and stored in manner that prevents mix-ups and provides proper identification LABEL ISSUANCE AND CONTROL

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All excess labels bearing batch numbers or other batch related printing should be destroyed. Obsolete and out dated labels should be destroyed. Printing devices used to print labels for packaging operations should be controlled to ensure that all imprinting conform the print specified in the batch production record.

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Printed labels is sued for a batch should be carefully examined for proper identity and conformity to specification in the master production record. The results of this examination should be documented. Printed labels representative of those used should be included in the batch production record.

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There should be documented procedure design to ensure that correct packaging materials and labels are used. Labeling operation should be design to prevent mix-ups . There should be physical separation from operations involving other intermediates or APIs. Labels used on containers of intermediates or APIs should indicate the name or identify code, the batch number of the product, and storage conditions, when such information is critical to assure the quality of intermediates or APIs. Packaging and labelling operations

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If the intermediates or APIs is intended to be transferred outside the control of the manufacturer’s material management system, the name and address of the manufacturer, quantity of the contents, and special transport conditions and any special legal requirements should also be included on the label. For intermediates or APIs with an expiry date , the expiry date should be indicated on the label and Certificate of analysis.

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For intermediates or APIs with a retest date , the retest date should be indicated on the label and Certificate of analysis. Packaging and labelling facilities should be inspected immediately before use to ensure that all materials not needed for the next packaging operations have been removed. This examination should be documented in the batch production records, the facility log, or other documentation system.

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The master batch packaging formula will provide the basis for each packaged dosage form. It will contain the following fields: Drug product name, identification number and strength Names, identification number and quantities of each packaging component: Primary container: bottle, closure and liner, foil, laminate, etc. Label Carton Insert Tamper-evident feature Child-resistant feature Master batch packaging formula

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Complete description of the equipment to be utilized for the packaging operation . Characteristics to be monitoring during filling and packaging (e.G., Temperature, fill, clarity, ph, specific gravity, color, cap tightness, seal integrity). Sample requirements and frequency For the specific batch being packaged: Batch number of the bulk drug product Packaging lot or control number assinged Quantities of packs expected and action level value Quantities of each packaging component issued Expiry date to be issued

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Definition: Packaging having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible or audible evidence to consumers that tampering has occurred. Scope: Tamper-evident packaging is to be applied to: Non-prescription and complementary healthcare products Prescription medicines Medical devices Two-piece hard gelatin capsule products Temper evident packaging

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Acceptable tamper-evident features: The packaging technologies listed below are considered to meet the requirements for tamper evident packaging provided that they are properly designed and appropriately used. Breakable caps: The cap can not be reapplied in its original state. Film wrappers: A transparent film with distinctive design is wrapped securely around the entire product container. The wrapper must have an identifying characteristic (e.g. a pattern, name, registered trade mark, logo or picture) that can not be readily duplicated.

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Blister or strip packs: Dosage units (for capsule or tablets) are individually sealed in plastic or foil. The individual compartment must be torn or broken to obtain the product. The backing materials can not be readily separated from the blister or easily replaced without leaving evidence of tampering. Bubble packs: The product and container are sealed in plastic and mounted in or on a display card. The plastic must be broken to remove the product. The backing material can not be readily separated from the bubble or easily replaced without leaving evidence of tampering.

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Heat shrink bands or wrappers: Bands or wrappers with a distinctive design (e.g. a pattern, name, registered trade mark, logo or picture) are shrunk by heat to seal the union of the cap and container. The seal must be cut to remove the product. Card board cartons: The carton seal must be cut or torn to remove the product and must not be able to be easily worked open and resealed without obvious damage to the carton The carton must be non-resealable without showing visible evidence of entry.

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Foil, paper or plastic pouches: The product is enclosed in an individual pouch that must be broken to obtain the product. The end seal of the pouches can not be separated and resealed without showing visible evidence of entry. For sterile medical devices, packaging is designed so that it can not be opened without obviously damaging the unit pack or seal of the unit pack, which is non resealable and carries a label statement “ sterile if in unopened undamaged pack ” or words or symbol to that effect. This type of packaging is considered to be tamper-evident without additional labelling requirements. Direct printing of the label on the container is preferred to use a label that could be removed and substituted.

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Sometimes medicines are packaged in container with child safety caps that can be reclosed after opening. These caps have to be squeezed and turn at the same time or pushed down and turn at the same time. Always make sure that the caps are put back on correctly. These safety caps may be difficult to open and slow down the time it takes for a child to get the contents, but they are not child proof. Some other medicines are packaged in strip foil, and blister packs . These are hard to open but van not be reclosed. Once open, the content are easily available to children. Safe storage out of sight and reach is the best protection from poisoning. Child resistance packaging

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What is Line clearance ? An important requirement of GMP is that the packaging and labelling facilities are inspected before use to assure that all drug product have been removed from previous operation and that packaging and labelling materials not suitable for subsequent operation have also been removed. Line clearance

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Procedure: The filling\packaging line and areas immediately closed to it should be free from all filled\packaged products as well as the packaging and labelling materials from the previous filling\packaging operation. Reject on the line such as inadequately filled bottles, broken or damaged packs, strips with empty pouches and then should also be removed and destroyed. Spillages on the line and immediate areas should be cleared.

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Particular attention should be paid to left-over labels and cartons with overprinted lot details from the previous run, especially when a new batch of same product is to be packed on line. It should be certified that packaging equipment has been properly cleaned and a tag (preferably green colored and marked ‘CLEANED ’). The tag should also indicate the date of cleaning and the name of the product for which the equipment was last used and should be signed by the supervisor .

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If the equipment has been idle even for a short period of time before use, it should be re-inspected for cleanness and re-cleaned before use, if required. The green tag should indicate the date of the new cleaning and should be initialed by supervisor. Information regarding cleaning of major packing equipment should be recorded in the ‘ Equipment Cleaning and Use Log ’ of the packaging department.

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If the line clearance is satisfactory, the relevant portion of the filling\packaging order should be filled and initiated by the supervisor. Filling or packaging of the batch should not commence until the clearance has been initiated by the supervisor on the filling\ packaging order. Where the filling\packaging has been interrupted, a new line clearance check has to be made. In such cases, all the materials should be returned, under close supervision to their respective identified containers until the new clearance has been made.

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OBJECTIVE AND SCOPE: To describe detail procedure of line and machine clearance for product\batch changeover to avoid product contamination or batch mix-ups. It is applicable to Solid Oral Packaging area. RESPONSIBILITY: Technician \ Officer \ Executive ACCOUNTABILITY: Production Head

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Following packing material shall be reconciled on completion of batch: Printed aluminum foil, PVC, imported foil Printed box, catch cover Insert Label \ shipper label Bottles , container On receipt of each of above packing materials from the day packing materials store, note down the quantity (Nos. \ Kgs.) in the packing material receipt record page of MPCR (Material Packing Card Record). Also note down any additional quantity received in the space given for additional packaging material in the packing material receipt record page of MPCR. Reconciliation of labels

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Note down the total quantity received (including additional if any ) in the space given on reconciliation page. Daily rejection of printed packaging material (cartons and inserts ) shall be recorded in the manpower distribution page of MPCR. After completion of packing , note down the following in the reconciliation page of BPCR: ‘Used in packing’ shall be calculated according to the quantity transferred to BSR (bonded store room ) Total on line packing material rejection retain \ other sample

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Printed foil More than 1 kg PVC \ Imported foil More than 2 kg Sticker label in roll form More than 100 Nos. If the left over quantity is more than monitored below, return it to warehouse and note down the total quantity in the column of return on reconciliation page. Subtract the quantity of packing material from used in packing, retain \ other sample, return packing material and rejection quantity from the total quantity received to find the reconciliation difference.

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The reconciliation difference shall be within the limit given below: Sr. no. Item % Acceptable difference 1 Printed foil, PVC, imported foil 2 % 2 Printed box 0.5 % 3 Catch cover 0.5 % 4 Label, shipper label 0.5 % 5 Insert 0.5 % 6 bottles\ PPCP container 0.1 %

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In case of difference exceeding acceptable limits, investigate the reason and document the reason in process deviation record. Remaining packing material leftover if any should be enter in to reconciliation of the MPCR.

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OBJECTIVE AND SCOPE: To describe the detail procedure for packaging material reconciliation. It is applicable to solid oral packaging department . RESPONCIBILITY: Packaging Officer and Packaging Executive ACCOUNTABILITY: Production Head

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Carton is the name of certain types of containers typically made from paperboard which is also sometimes known as “cardboard”. Sometimes carton is also called a box. Many types of cartons are used in packaging. Types of carton: Aseptic carton: Cartons used for liquids which can be fabricated from laminates of paperboard , foil and polyethylene. These are for aseptic processing and are used for milk, soup, juice, etc. Cartons and other packaging materials

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Folding cartons: A carton is a type of packaging suitable for food, pharmaceuticals and many other types of products. These are usually combined into a tube at the manufacturer knocked down to the packager. Tray styles have a solid bottom and are often shipped as flat blanks and assembled by the packager. High speed equipment is available to set-up, load and close the cartons.

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Gable top: Gable top cartons are used for liquid products such as milk, soup, juice, etc. These are used polyethylene coated paperboard and sometimes a foil laminate . They are opened by pushing open the gables at the top. Some have fitments to assist in opening and pouring the contents.

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Materials: Cartons can be made from many materials like paperboards, various plastics or composite. Some are “food grade” for direct contact with foods. Many cartons are made out of a single piece of paperboard. Depending on the need, this paperboard can be coated or waxed with polyethylene to form a moisture barrier. This may serve to contain a liquid product or keep a powder dry.

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Type of materials: Plastic: This is the most common packaging material but one of the most difficult to dispose of. All plastics are light & cheap to manufacture. It is for these reasons that they are used so much, as an alternative to cardboard glass packaging materials. .

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Metal: For packaging foods, for drinks, such as soft drinks beers, aluminium i s often used. Tin plate is a solid, heavy steel covered with tin to protect it against rust. It is used to package canned foods. Aluminium is attractive, light strong , but requires a lot of raw materials energy to make it. For this reason it must be recycled. The majority of cans of soft drinks, lids, aluminium foil, etc. are made aluminium.

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Brick carton: A light, strong air-tight packaging material. Ideal for transporting storage . It is becoming the main packaging material used for basic foodstuffs. Complex packaging material, made up of several layers of plastic, paper aluminium. It is also difficult to recycle . It is used mainly to keep drinks such as milk, juice, etc.

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Cardboard: Appropriate for packaging materials wrapping. Its use may prove to be unnecessary when used for products which are already packaged sufficiently. In all cases, this packaging material is easy to recycle reuse. It is used in the form of boxes, sheets cardboard.

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Glass : An ideal material for foods, especially liquids . It is inalterable, strong, easy to recycle. It is the traditional vessel in the home (jars, glasses, jugs, bottles, etc.). Its weight & shape may involve some difficulties for transport storage.

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Other packaging materials: Containers should provide adequate protection against deterioration or contamination or API that may occur during transportation and recommended storage. Containers should be clean and sanitized to ensure that they are suitable for their intended use. These containers should not be reactive, additive or absorptive so as to alter the quality of the intermediate or API beyond the specified limits.

REFERENCE:

REFERENCE Sidney h. Willing ; “Good manufacturing practices for Pharmaceuticals” ; 5 th edition:137. http://in.answers.yahoo.com/question/index?qid=20090825002524AAdenEj http://www.gmplabeling.com/home/index.php http://www.google.co.in/search?hl=en&safe=active&q=gmp+for+printed+materials&aq=f&aqi=&aql=&oq=&gs_rfai

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