Handling of consumables in pharmaceutical industries
If I am talking about material management system, we do all the thing to comply the regulatory requirement; Raw material supplier qualification, raw material technical evaluation, testing etc. but to comply all these requirement we forgot all the consumables which can directly or indirectly influence the quality of final products.
Now lots of question will come in mind like; What is consumables How we can categorized? How can we control? etc. etc. So let us understand first what is consumables Consumable is key materials which are used in support of manufacturing or which is coming in contact with the product during manufacturing that may not become part of final product.
Consumable can be categorized in three category
(i) Direct quality impacting consumables
(ii) Indirect quality impacting consumables
(iii) Non-quality impacting consumables
Direct Quality Impacting Consumables:
If any consumable fall in the below categories shall be treated as DIRECT QUALITY IMPACTING consumable and to be tested and release from quality control unit before use.
- Is material in direct contact with final product, raw material or intermediate; e.g. polybag, gasket, finger bags, product filter etc. Is the consumable use in the critical utilities which is directly affect the product quality, safety, efficacy; e.g. compressed air filter, dosing chemical use in water pretreatment.
- Is the consumable use for the cleaning of equipment surface which come in direct contact of product; e.g. CIP chemical , equipment sanitizing agent like IPA.
Indirect Quality Impacting Consumable:
Any consumables which are not come into indirect contact with product or its starting and intermediate material shall be treated as INDIRECT QUALITY IMPACTING. Some of the indirect quality impacting consumables examples are given below but not limited to
Hand sanitizing agent
Non-quality Impacting consumables: Any consumable which is not affect the quality of product directly or indirectly shall be treated as non-quality impacting consumable. All these quality impacting (both direct and indirect quality impacting consumables) can leads serious defect if quality of all these consumable not evaluated properly before use in the manufacturing and packaging of products. There should be a matrix to categorized the consumables based on the above questions which should be continuously update Before taking any material supplier for direct impacting and indirect impacting consumables should be quality based on some questionnaire, site audit wherever critical consumables, by ensuring TSE declaration, food grade certificate etc. So safe your consumable, safe your product and finally safe the patient