Quality control ensures that the drug substance and other raw materials are suitable for use in the drug product and that the products manufactured for sale meet the highest quality standards. The department carries out a number of tests as per the specifications on various raw materials, intermediates and finished products. Raw materials are not released for production or finished products are not released for sale unless and until they are approved by the quality control department. Ethical practices should be followed especially by this department because testing if not performed as per the specifications can result into increased rejections/recalls and complaints from the market. The ultimate aim of any drug manufacturing procedure is to ensure that the drug has the required identity, strength, potency, purity and quality. Testing will not only control the quality but it is also important that the entire process from procurement of raw materials to final distribution of the drug in the market is validated. It is important to know the subject well if ethical practices have to be followed.
Assays in the QC department are not performed up to the mark and a lot of malpractices are followed either in the procedure or calculations. Proper techniques should be followed in handling of all the reagents and in preparation of the standards.
Ethical practices in documentation should never be practiced and data to be shown to the regulatory authorities should not be forged to get approvals. SOPS should be critically followed. All entries have to be written in ink along with the date/sign/initials of the responsible person. Spectrums obtained from analytical techniques should never be changed neither should one manipulate the readings. Cleaning of equipments should never be done carelessly else there is a huge possibility of cross contamination from the previous batch. It is important to inculcate the importance of this industry to the work floor personnel who perform the cleaning operations. Proper gowning and hygiene in all the departments should be followed to avoid contamination. Illness of any kind should be ethically reported to the supervisor. Not only can this affect the drug product but also the other personnel working in the organization. In a highly regulated industry such as Pharma, every drug has to be carefully manufactured because a small mistake can affect many lives. Ethics combined with regulations can give a consistent product with batch to batch uniformity and reproducibility.
Mrs. Nikita Sanghavi,