REGULATORY GUIDELINES FOR PACKAGING MATERIALS

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Information about REGULATORY GUIDELINES FOR PACKAGING MATERIALS
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Published on June 28, 2014

Author: sohnivya

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REGULATORY GUIDELINES FOR PACKAGING MATERIALS: VIJAYA INSTITUTE OF PHARMACEUTICAL SCIENCES FOR WOMEN REGULATORY GUIDELINES FOR PACKAGING MATERIALS Submitted by, Md. Jaha sultana, 137N1S0008 Submitted to, N. SUPRIYA, Department of pharmaceutics 1 DEFINITION:: DEFINITION : This can be defined according to US FDA regulation as “The package should preserve the integrity i.e. the purity, identity, strength, and quality of the drug for the entire period of its stated shelf life”. 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 ; 2 REGULATORY GUIDELINES FOR MASTER PACKAGING INSTRUCTION:: REGULATORY GUIDELINES FOR MASTER PACKAGING INSTRUCTION: A formally authorized master packaging must include the following points: Name of the product. Description of dosage form, strength and composition . The package size is expressed in terms of number or doses or weight or volume of the product in the final container. All packaging materials must have a standard batch size , including quantities sizes and with code or reference number. The packaging materials must contain batch number and expiry date. Equipments used must also be mentioned in case of packaging materials. Details of in process controls with instructions for sampling and acceptance. Upon completion of the packing and labelling operation reconciliation should be made. 3 TESTING AND INSPECTION OF PACKAGING MATERIALS:: TESTING AND INSPECTION OF PACKAGING MATERIALS: The testing and inspection of packaging materials should be recorded and be in accordance with the master specifications. The testing record should include:- Date of sampling and date of testing (or inspection). Name and quantity of material. Any batch identifying number Results of all testing and inspection . Names of person (s) who carried out tests or inspection. Analyst’s signature 4 CONT…: CONT… During packaging the following should be entered into batch packaging records at the time that each action is taken. The batch number and the expiry date of the bulk product to be packed. The date and time of commencement and completion of packaging and of significant intermediate stages. Details of the persons who conformed there correct identity and quantity. The total quantity of packaging material used with batch identifying reference to primary and printed packaging materials. A record of packaging machine , lines or area used. Records should be maintained for amount of bulk product supplied, printed materials issued and finished packs. 5 CONT…: CONT… Packaging materials are generally divided into following categories: Primary packaging materials: The materials which come in contact directly with the primary material products. E.g.: vials, Syringes, Ampoules, Flexible bags, Bottles and Clousers . 2. Secondary packaging materials: Materials comes in contact indirectly with the primary materials E.g. labels, foils. 3. Printed packaging materials : All packaging materials which have anything printed on it. E.g. labels, foils. 4. Tertiary and other packaging materials : All the packaging materials other than those covered in the above categories. 6 CHARACTERISTICS OF PACKAGING MATERIALS:: CHARACTERISTICS OF PACKAGING MATERIALS: It should maintain the integrity of the product though out the shelf life. It should be impermeable to moisture, gases, vapour, and microbes. It should be inert and non-reactive with the product. It should not allow microbial growth . It should maintain colour, odour, taste of the product. It must be non-toxic . It should protect the photosensitive drugs. It must be tamper resistant . It must be with in economic range. It must be approved by FDA. 7 QUALIFICATION AND QUALITY CONTROL OF PHARMACEUTICAL PACKAGING COMPONENTS: QUALIFICATION AND QUALITY CONTROL OF PHARMACEUTICAL PACKAGING COMPONENTS A packaging system found acceptable for one drug product is not automatically assumed to be appropriate for another. Each application should contain enough information to show that each proposed container closure system and its components are suitable for its intended use. The type and extent of information that should be provided in an application will depend on the dosage form and the route of administration. 8 EXAMPLES OF PACKAGING CONCERNS FOR COMMON CLASSES OF DRUG PRODUCTS: EXAMPLES OF PACKAGING CONCERNS FOR COMMON CLASSES OF DRUG PRODUCTS D e g ree of Con c e rn Asso c iat e d with t he Route of a dm i nis t r a t i on P ACK A G I NG COMP O NE N T - D O S A G E F ORM I N TERAC T I ON H I GH ME D I UM L OW H I G H EST I n h a lation A e rosol a nd S olu t ion ; I nj e c tabl e s S te r i l e powd e r a nd powd e r of in j ec t i on ------------ H I GH Ophth a l m ic solution, suspensions, Tr a nsde r mal P a tch e s, nas a l sp r a y s ------------ ------------ L OW Topi ca l so l ut i on, suspensions. A e rosol, O r a l so lution , suspensions. Topi ca l P owd e rs O ra l P owd e rs O ra l T a blets a nd Capsule 9 GENERAL CONSIDERATIONS: GENERAL CONSIDERATIONS DESCRIPTION SUITABILITY PROTECTION COMPATIBILITY SAFETY PERFORMANCE QUALITY CONTROL STABILITY 10 PowerPoint Presentation: SUITABILITY: Suitability refers to the tests and studies used and accepted for the initial qualification of a component or a container closure system for its intended use. Every proposed packaging system should be shown to be suitable for the intended use. It should protect and compatible and composed of material that are considered as safe for use with dosage form PROTECTION A container closure system should be providing the dosage form adequate protection against cause of degradation like: light, temp, loss of solvent, exposure to reactive gases, microbial contamination. Laboratory studies can be used 11 PowerPoint Presentation: COMPATIBILITY Compatibility between packaging component and the drug substance and excipients should be determined. Absorption or adsorption cause loss of potency, brittleness of packaging component and leaching can lead to degradation, precipitation, change in drug pH, discoloration SAFETY Components should not leach harmful substance to which a patient will be exposed when being treated with drug products. For injection, inhalation, ophthalmic, or transdermal , a comprehensive study is appropriate like Extraction study on the packaging components to determine which chemical species may migrate in to dosage form and then toxicological evaluation of those substances 12 PowerPoint Presentation: PERFORMANCE Ability to function in the manner for which it was designed. Evaluation of performance include: Container closure system functionality The container closure system may be designed to improve patient compliance (e.g., a cap that contains a counter), Drug delivery Drug delivery refers to the ability of the packaging system to deliver the dosage form in the amount or at the rate described in the package insert. E.g.: prefilled syringe, a transdermal patch, a metered tube, a dropper or spray bottle, a dry powder inhaler, and a metered dose inhaler. 13 PowerPoint Presentation: STABILITY 14 PowerPoint Presentation: QUALITY CONTROL OF PACKAGING COMPONENTS 15 PowerPoint Presentation: TABLE 3:- APPLICATION FOR ANY DRUG PRODUCT Description F or e ac h p a c k a g i n g c o m pon e nt : N a me, Produ c t co d e , M a nuf a c tu r e r, P h y s i ca l des c ription Mat e ri a ls of c onstr u c t i on D e s c ription of a n y a ddi t ional tr ea t m e nts or p r e p a r a t i on. S ui t a bi l i t y P rot ec t i on : S a f e t y : L i g ht e x posure ♦ Chemic a l composit i on R eac t i ve g a s e s ♦ E x tr ac tabl e s Compatib i l i t y : P e r f o r ma n c e : I nt e ra c t i on ♦ F un c t i on a l i ty P ost app r ov a l s t a bi l i t y s t udies ♦ D r u g d e l i v e r y Qu a l i t y Control F or E a c h P ac k a g ing C o mponent R ece ived b y the Applic a nt Applic a n t ` s test and a cc e ptan c e c rite r ia Dimensional a nd p e r f o r man c e c rite r ia Method to moni t or c onsisten c y in c omposi t ion B ri e f d e s c ription of M f g. P ro c e ss S tabil i t y Contain e r c losure s y st e m should be moni t o re d for si g n of instabil i t y . 16 PowerPoint Presentation: TABLE 4: LIQUID BASED ORAL & TOPICAL DRUG PRODUCTS AND DELIVERY SYSTEM D e s c ription F or E a c h P ac k a g ing C o mponent : N a me, Produ c t co d e , M a nuf a c tu r e r, P h y s i ca l des c ription Mat e ri a ls of c onstr u c t i on P ro c e dur e s for w a shing c omponents S ui t a bi l i t y P rot ec t i on : C ompatib i l i t y : As p e r l a st t a ble L DPE & Gl a s s - USP c ontain e r t e st i ng m i c robi a l cont a m i n a t i on Co a t i ng in te g ri t y t e st i ng Safety: P e r f o r man c e: Topi ca l Dr u g P dt . : USP Contain e r t e st i ng F un c t i on a l i t y a nd/or d r u g d e l i v e r y Topi ca l D e l i v e r y S y st e m : a ppro p ri a te r e f e r e n c e ind i r e c t food a ddi t ive r e g ulation Qu a l i t y Control As p e r l a st t a ble S tabil i t y As p e r g e n e r a l f o rm a t g iven b e fo r e 17 PowerPoint Presentation: TABLE 5: SOLID ORAL DRUG PRODUCTS AND POWDERS D e s c ription Ov e r a ll g e n e r a l d e s c ript i on of the c ontain e r c losu r e s y stem plus S ui t a bi l i t y P rot ec t i on : C ompatib i l i t y : As p e r l a st t a ble L DPE & Gl a s s - USP c ontain e r t e st i ng m i c robi a l cont a m i n a t i on Co a t i ng in te g ri t y t e st i ng S a f e t y : T a blet, C a psule : app r op r iate re f e r e n c e to i ndir e c t food a ddi t ive re g ulation R a y on a n d c ot t on filt e rs : USP mono g r a ph D e ss i ca nts : si z e a nd sh a p e should dif fe r f r om t h a t of dos a g e f o rm P e r f o r man c e : F un c t i on a l i t y a nd/or d r u g d e l i v e r y Qu a l i t y Control As p e r l a st t a ble S tabil i t y As p e r l a st t a ble 18 PowerPoint Presentation: THANK YOU !!! 19

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