This audit report of numerous components of packaging of a pharmaceutical product X is targeted at ensuring that the medicine arrives safely in Ireland’s manufacturing company where the drugs are then repackaged and distributed to hospitals, pharmacies and patients via the wholesale subsidiary in Ireland. Packaging of drugs and related items refers to the combination of distinct elements like bottle, closure, vial, blister and ampoule among others, which surround the pharmaceutical manufactured goods from the time they are produced until the time they are used up (FDA, 2004). The system of value guarantee for the manufacturing of pharmaceutical goods should make sure the preparations are made for the manufacture, distribution and use of the right preliminary and packaging materials. The main aim of this audit report is to develop an audit plan and a checklist for the audit which comprises of all the requirements for packaging and distribution of product x (Reinhardt & Gordon, 2001).
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The ultimate aim of packaging medicinal products is to protect them from any unnecessary conditions like extreme temperature, dirty, spoilage and misuse (Ross, 1995). Consequently, the products are packaged in containers that are conventional to the prescribed standards especially with concern to the omission of moisture and light as well as prevention of percolating of extractable materials into the substances and of chemical intermingling with the contents. Nevertheless, the constraints of suitability in these numerous respects depend in part of the climatic flexibility (Snyder, 2002a). Therefore, the recommendations in the global pharmacopoeia are that, specific quantitative customaries must be locally determined. This means that since product x tablets are to be moved to Ireland, their quantitative standards are to be determined in Ireland. The difficulty of packaging products and the intensive technological nature of medical substances are such that manufacturers are challenged with massive problems (Lockhart & Paine, 2006). Nevertheless, the association of packaging and such substances is achievable since there is the combination of numerous container elements and lively pharmaceutical ingredients and usage of solvents in different forms (The international pharmacopoeia, 2004). The quality of wrapping pharmaceutical substances plays a significant part in the quality of such substances. This means that packaging:
- Can protect the product against all unfavorable environmental effects that can change the properties of the product. These may include things like light, moisture, oxygen and temperature variations.
- Packaging guards the product against biological contamination
- Packaging prevents physical damage of medicinal products.
- Packaging contains the right information and identification of the product.
The process of selecting the packaging material is also significant because the choice must be done in a manner that the packaging itself does not have unfavorable influence on the product like leaching, chemical reaction and/or absorption (Leonard, 2006). It should also not have unfavorable influence on the packaging altering its properties as well as having an effect on its protective functionality. Therefore, before deciding to move the X tablet to Ireland, these packaging principles must be observed in order to make the whole process safe and successful. It is also imperative to observe that when the product arrives at the subsidiary manufacturing organization in Ireland, the entire process to be undertaken must meet the World Health Organization’s requirements before submission to the wholesale subsidiary for distribution (Jenkins & Osborn, 2003).
Action Plan Development
General considerations and requirements of Packaging
Packaging as mentioned, is the process of bringing together distinct components like bottle, closure, which enclose the pharmaceutical substance like product x tablets from the production time until its use (Guide to packaging, 2000). The significant aspects of packaging to be taken into consideration include:
- The purpose of packaging
- The selection of packaging matter
- The testing of material selected
- Filling and accumulating
- Storage and stability
Packaging materials may encompass print out materials used in the packaging of pharmaceutical product, though not for any outer packaging employed for transportation of the medicinal tablets (Reinhardt &Gordon, 2001). Some examples of types of materials used in packaging are as shown in the table below.
|Types of raw materials used in packaging|
|Types of materials||Uses|
Laminating with paper or foil
|Metal like aluminum||Collapsible tubes |
|Rubber||Closures encompassing plunges|
Note that a difference exists between primary and secondary packaging elements like closures, bottles, blisters among others that are in direct physical contact with the substance, while the secondary elements are not in straight contact with the goods and may include aluminum caps and cardboard boxes (Snyder, 2002b). The selection of primary or secondary packaging materials normally depend on the level of protection needed, compatibility with the substance, the filling technique used and its cost as well as on the presentation for over-the-counter (OTC) drugs (British Standard, 2009).
Nevertheless, the product x tablets must be packaged in bottle tops with desiccant plugs in the bottle tops so that it appears original and untouched (FDA, 2003). The bottles are then placed in a carton which also encloses the patient information leaflets for the tablets.
This report looks at the best way of packaging and distribution of medicinal tablets in Ireland. The method used in this report thorough research on packaging issue. Study is done on the aspects of suitability for packaging and distribution of drugs in Ireland (Gennaro, 2000). Therefore, the audit examines two major subsidiaries in Ireland; one with license to manufacture and package drug and one for distributing the drugs in wholesale terms.
The outcome of appropriate packaging and transporting the medicinal tablets to Ireland subsidiaries is safe delivery with all the tablets intact as they were packed. After delivering them to the subsidiaries, the tablets are then repacked well for distribution to pharmacies in Ireland and to users. One of the most important concepts considered before repackaging and distribution process is labeling and ensuring they contain the trademark symbol to show approval from the WHO (WHO Expert Committee, 1997).
Labeling is one of the most significant concepts of packaging because it helps to identify the type of drugs and their specification particularly when different kinds of drugs are enclosed in one container. Throughout the manufacturing process, a sequence of precise outer labels is attached to the container of the packaged product (Cooper, 2004). The degree of processing is shown by the following words;
Quarantine, Storage, and Distribution
Precisions of labels for accomplished drug products are described in the WHO directions under pharmaceutical products and must be followed to the fullest in order for WHO to approve the drug (Snyder, 2002a). The labels contain information like the active ingredients used in manufacturing of the drug, the dosage form, the trademark and preservation of the tablets. The labels give advice on how the tablets are to be stored. For instance, product x must contain this label: “store between temperatures 2 and 8°C under refrigeration. Caution, no freezing. Other information available on the label include the batch number that helps to follow the distribution route for the product from the manufacturing procedure its administration and to the patient. This means that for tablet x, the butch number is followed by the follow up route, which entails the Ireland subsidiary manufacturing company and the subsidiary that holds a wholesale license. This helps the patient to locate and recognize the product thus has confidence when using it.
Dissemination of Results
The results of packaging the x tablets were successful because all aspects were considered and implemented especially during labeling of the tablets. The next step is the distribution of the tablets to pharmacies and clients in Ireland. This process involves different environments and people from different regions. Several staffs are involved from the two subsidiaries, but the majority of them are from the wholesale subsidiary. The clinical governance implementation group decides the lines of dissemination (Cooper, 2004). The function of this group is to come up with the best protocol to follow in the distribution process. The protocol employed in distributing tablets x is from the manufacturing subsidiary where the process of packaging is done to the wholesale subsidiary. The wholesale subsidiary then supplies the medicinal drugs to its agents who then distribute them to other wholesales in different regions of Ireland. These wholesalers then distribute the drugs to the retailers of their specific regions and then to clients or users of the drugs (Lockhart & Paine, 2006). The subsidiary wholesale is also responsible for distributing the medicinal drugs to different national hospitals as well as regional hospitals present in the whole country. After three weeks to one month, the x tablets will be available to patients all over Ireland and their effectiveness would be felt in a short while.
British Standard, 2009,. Specifications for packaging resistant to opening by children. London: British Standards Institution.
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