Significant Elements of a Quality Master Data Management

A good quality and efficient master data management system in a pharmaceutical firm can significantly improvise the superior quality medicines for patients, net profit status, less recall and rework that can save not only a huge amount of money but also provide a good working environment and norms as per national and international regulations and authorities. Quality management is like a philosophy and it takes thorough understanding, commitment and engagement to introduce as well as deploy the concept. Once acknowledged and applied a good quality and efficient quality management system creates or reshapes a sustainable firm culture that pays off instantly and within less time period.

Some key and significant elements of quality assurance to be taken care of while managing MDM pharma applications are mentioned in the post.

·         Standard operating procedure – Along with preparing forms, manuals and templates, they should be used for keeping a track record and a routine of people.

·         Documentations – It is mandate to build qualitative and sound master files and documents to have a good master data management system for your websites. There should be proper documentation, approval and retention requirements defined for effective communication in between varied processes.

·         Quality management and change control – There is a need to create procedures depicting how to generate new quality documents, review of the documents, change control of existing ones, approvers, document control officer, role of document author and satellite file administrator. In such defined system, the numbering has to be done of different quality documents including templates, audit files, SOPs, manuals, forms, QA agreements, training files, project files and their respective archiving system.

·         Preparation, maintenance and change control of documents – Procedures and processes to be defined entirely focusing on the management of master file documents including control methods, specifications, finished goods, raw materials and packaging specifications like stability files, test reports and formulation to generate during the product registration in the marketplace.

·         Deviation report system – Been a regulatory and authorized requirement to grab all the deviations needed to be in your system in respect to maintain the continual improvisation of your processes and systems. Procedures have to be build describing how to segment the deviations in between audit, production, technical deviations, quality improvements, environmental and customer complaints, safety and health deviations.

·         Selection and Evaluation – During the vendor evaluation and assessment, procedures should be followed for buying raw materials, laboratory supplies, both critical and non critical packaging constituents, engineering supplies and imported finished goods.

·         Vendor certification – The procedure focuses to describe the process and services by which a vendor may be certified to supply materials and services.

·         Product compliant procedure – There should be a strong and sound procedure to cover all facets including logging, receipt, evaluation, reporting and investigation of all complaints received from customers for the advertised and promoted products. The procedure should involve step by step edifications to be followed involving registration and numbering of complaints, evaluation, determination and implementation of preventative activities, handling of counterfeit products and trending of complaints.

·         Rework procedure – Procedure is needed and followed step by step especially when the rework of an in process or finished goods is demanded.  

·         Annual product review – It is must to do annual product review along with evaluation of key trends, data and identify corrective and preventive actions leading to product quality improvements and reporting them to management respectively.            

·         GMP audits – Procedure should be created to describe the procedure of planning, reporting, performing and follow up of different audits for your systems including environmental health, internal quality audit, safety audit, vendor audit and EHS workplace inspection.

There are firms offering and following all norms as mentioned while integrating MDM pharma solutions in small, medium and large sized organizations. Helpful in enhancing productivity and performance of your business, master data management solutions are the need of today’s technological and advanced era.