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Quality Management
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Sara Quality Management |
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The policy envisages producing products of the highest standards and every activity contributes directly or indirectly to the quality standards should strictly adhere to the quality norms laid down. Quality is built into the system with emphasis on stability studies,in process controls and assurance of quality right from raw materials, packing materials, intermediates to finished products. Every Employee should consider quality as an attitude and not a mere guideline.
Quality assurance covers all the organized arrangements made individually/collectively with the object of ensuring that the products will be of required quality. Quality assurance is entrusted with the responsibility of product design and development taking into requirements of GMP.The function of quality assurance is to envisage that the expected quality control is achieved in all activities from Raw material purchased to finished analysis through factory upkeep.
The element of quality assurance systems involve and are concerned with sampling,specification and testing and with the organization,documentation and release procedures which ensure that the necessary and relevant tests,are infact,carried out and that the materials are not released for use,nor products for sale or supply until their quality has been analyzed to be of the company's standards.
Self inspection is carried out for the purpose of evaluating the quality system.Rolling audit is carried out once a month covering buildings & Ground and equipments, personnel hygiene; Documentation; Manufacturing procedure; Quality management; use of computers. It includes compliance of cGMP.
The finished product is released for sale after certification from the quality control who decide on results of analysis and from Quality Assurance cell based on inspection of all documents including in process controls.
Standards such as ISO 9001-2000 are followed.
Vendor assessment is made by assessing their market standing, facilities and supply position. After the evaluation of quality of their sample for specification, a trail order is made for the formulation study at R&D level. Upon satisfactory results of the trails, the supplier is included in the vendor list.
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Drug product stability program |
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- Assigning a provisional shelf based on accelerated stability studies.
- Reviewing the shelf lif on the basis of results of analysis of samples kept at actual room temperature.
- Continuous monitoring of the quality through the analysis of retained samples.
- Regular examination of retention samples for physical changes like colour/ clarity/ consistency/ flavour/ disintegration time.
- Monitoring the adequecy of the program through field reports/complaints received.
- Monitoring of the efficacy of preservatives
- Revision of shelf life when warranted.
Prior to launching of a new product, trial batches are carried out on a small scale & various parameters are analyzed and checked by subjecting the product to accelerated stability studies. Once the the trial batch is found to be acceptable, then batch size is scaled up and regular production commences. The finished product is also subject to shelf life studies that reflect the average storage condition in the market by analyzing at regular intervals and critically reviewing the results.
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