In the manufacture of pharmaceutical products, quality assurance is defined as “the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use”.
In addition, the system of quality assurance for the manufacture of pharmaceutical products should ensure that “arrangements are made for the manufacture, supply and use of the correct starting and packaging materials”
Public opinion sometimes considers packaging to be superfluous. However, it must be emphasized that packaging preserves the stability and quality of medicinal products and protects them against all forms of spoilage and tampering.
A Pharmaceutical container is a device that holds the drug and may be in direct contact with product. If the container is in direct contact with the drugs it is called an immediate container. (Or) It is a device which holds the drug (or) the drug product either directly (or) in an indirect form. In some of the containers product may not be in direct contact with i.e. each unit is packed in a sachet and all of them are stored in containers. Ampoules packed in a container.
It is a device which protects the drug (or) drug product by preventing the entry of air, moisture, particulate matter, and microorganisms etc., thereby keeping the product in a safe condition and also assists in proper use of the drug.
Packing: Packing consists of enclosing an individual item, or several items, in a container, usually for shipment or delivery. This operation is mostly done by hand and machine.
Pharmaceutical Packaging: Pharmaceutical packaging means the combination of components necessary to contain, preserve, protect and deliver a safe, efficacious drug product, such that at any time point before expiration date of the drug product, a safe and efficacious dosage form is available.
1. Primary Packaging: This is the first packaging envelope which is in touch with the dosage form or equipment. The packaging needs to be such that there is no interaction with the drug and will provide proper containment of pharmaceuticals. E.g. Blister packages, Strip packages, etc.
2. Secondary Packaging: This is consecutive covering or package which stores pharmaceuticals packages in it for their grouping. E.g. Cartons, boxes, etc.
3. Tertiary packaging: This is to provide bulk handling and shipping of pharmaceuticals from one place to another. E.g. Containers, barrels
Packaging must meet the following Requirements: [ideal requirements]
• Protect the preparation from environmental conditions.
• Non-reactive with the product and so does not alter the identity of the product
• Does not impart tastes or odors to the product
• FDA approved
• Protect the dosage form from damage or breakage
• Meet tamper-resistance requirements, wherever applicable.
• Adaptable to commonly employed high-speed packaging equipment.
Criteria for the Selection of package type and package material
• Compatibility with the contents
• Strength of container and the degree of protection required
• Resistance to corrosion by Acids or Alkalis
• Resistance to grease
• Protection against salt
• Resistance to microorganisms
• Resistance to insects and rodents
• Resistance to differences in temperature
• Protection against light, fire and pilferage
• Odor retention and transmission
• Aesthetic effect
• Machine suitability of packaging and the filling method
Possible Interactions between primary packaging materials and the included pharmaceutical product:
• The release of chemicals from components of the packaging materials
• The release of visible and/or sub visible particles
• The absorption or adsorption of pharmaceutical components by the packaging materials
• Chemical reactions between pharmaceutical product & the packaging materials
• The degradation of packaging components in contact with the pharmaceutical products
• The influence of the manufacturing process (e.g. sterilization) on the container.
Presentation and information
Packaging is also an essential source of information on medicinal products. Such information is provided by labels and package inserts for patients.
The information provided to the patient may include the following:
• The name of the patient;
• The identification number for dispensing records;
• The name, strength, quantity and physical description or identification of the medicinal product;
• Directions for use and cautionary statements, if applicable;
• The storage instructions;
• The date of dispensing and period of use (related to the expiry date);
• The name and address of the dispenser.
Repacking, relabeling and dispensing
In some countries, it is common practice not to dispense drugs in the original packaging, but rather in a personalized manner to each patient. This applies especially to solid oral dosage forms, and involves the “repacking” and “relabeling” of drugs in small quantities. Different drugs may even be included in “customized” medication packages, also referred to as “patient med packs”. The quantities of drugs supplied in this way are usually enough only for a short period of time, i.e. to provide drugs for immediate use. It should be remembered, however, that data obtained in stability studies undertaken by the manufacturer are no longer valid for drugs removed from the original package.
Where repacking and relabeling are necessary, the WHO guidelines on GMP for pharmaceutical products should be followed to avoid any mix-up or contamination of the product, which could place the patients’ safety at risk.