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 requirements 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 into 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 the material in direct contact with the final product, raw material, or intermediate; e.g. polybag, gasket, finger bags, product filter, etc. Is the consumable use in the critical utilities which 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 comes in direct contact of a product; e.g. CIP chemical, equipment sanitizing agent like IPA.
Indirect Quality Impacting Consumable:
Any consumables which do not come into indirect contact with the 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 to serious defects if the quality of all these consumables 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 updated 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
To ensure the qualify function and adequate control, all the directly impacted consumable manufacturer’s facility should be audited, and once found all the system and process adequate then only technical agreement should be signed between both parties.
There should be a defined frequency to audit for all the direct impacted manufacturers and the audit schedule should be available with the site.
Periodically, all the associated documents should be reviewed for its correctness and validity. Critical consumables equally impact the final product quality as raw materials that are used in the formulation so we should treat direct contact critical consumable equally as raw materials.
You can prepared your site-specific procedure on handling of consumables by referring to this article.