Life sciences companies like pharmaceutical, biotechnology industries are obligated to comply with local and international regulatory standards in addition they being highly technology based. Technology is the science applied to industrial arts and cannot be treated as a single independent variable as it requires an understanding of how it is used in an industry and what production goals the stakeholders aim at. This is an onerous task. The first step is to electronically capture records and documentation of the product specifications from the time it emerges from R&D through the time it matures into a production offering.
Electronic records: Pharmaceutical industries are extremely information-intensive enterprises. Maintenance of Electronic records and files (Master formula records, Batch manufacturing, Drug master and site master files etc.,) serve compliance and guide in the manufacturing process by generating data and controls. Similarly electro-nic Standard operating procedures for machine, process operations and manpower provide a ready reference while navigating through the manufacturing process. These records also guide the flow of information right from the stage of obtaining, confirming the accuracy, organizing and categorizing, processing and indexing, storing, retrieving, analyzing, interpreting and communicating it to all the necessary points.
Integration: The key is to integrate financial management to supply chain, Manufacturing and Relationship Management with particular emphasis on quality control & assurance while ensuring accuracy, dependability and reproducibility of information within the organization with the required validations, in-process controls and checks during stage wise operations
Strategic Business Units: Life Science companies typically treat contract manufacturers and Loan licensees of the principle company as individual strategic business Units for which segregated profiles are mandatory
Inventory Control: vendor identification, evaluation, Qualification, rating, Quarantine management and differentiation of item groups as per pre determined categories whether Raw Material or Packing material. This serves as a safety measure while handling hazardous and toxic chemicals as the looks-ups and alerts form precautionary measures for the end user.
Labelling: Tailor made status labels for products and samples should be generated by the system for immediate use in situ.
Quality control: Should ideally offer automation in process calculations and generate the certificate of analysis for necessary approvals. Option for selection of sampling plan and sampling size and assurance issues.
Production: Some of the characteristic requirements are calculation of raw material purity, reconciliation of raw material and packing material (primary and secondary), Identification of product and process variables, deviations and yields. Establishment of historical data and guidance for current validation data, definition through specified routing as process or machine centers
Machinery: Design qualifications, installation qualifications and performance qualifications for the equipment and machinery should be established and tracked
In addition to the key pain areas in production other pain areas identified within the gamut of life sciences companies are:
.Pilot and scale-up operations
.Filing of ANDA and NDA-paper and e-submissions
.Knowledge management and statistical analysis during R&D.
.Tracking and pooling the post marketing surveillance data for Phase IV studies.
(The author is CEO of B2B Software Technologies)