One of my Google blog search RSS feeds on batch processes alerted me to an article, The New Recipe for Pharma Success. It describes how many Life Sciences manufacturers use low-tech tools like spreadsheets, flow charts, and other unstructured documents to create and maintain the process definitions. It concludes:
Bottom line, unstructured documents needlessly increase expenses and prolong time to market. Bad data may be introduced–or good data may be overlooked–at any stage of the product lifecycle, requiring companies to repeat one or more stages.
I ran this post by Joanne Salazar (perspective21 for you Twitterers out there.) Joanne has many years of experience with Emerson and is extremely knowledgeable of the regulatory compliance challenges pharmaceutical and biotech manufacturers face. She is currently focusing her efforts on the Compliance Suite manufacturing operations software, which joined the Emerson family last summer.
Joanne wrote back such a great reply, I thought it best to include in its entirety:
Pharma companies spend lots of money and lose valuable time bringing drugs to market as the patent expiration dates move ever closer. The data involved in defining the “recipe” for the drug is voluminous and needs to be managed throughout its lifecycle. Companies are gaining efficiencies to quickly startup production facilities in several ways:
- integrating change control between development and operations as a drug facility is brought online
- creating reusable libraries of process operations using S88 and S95 standards as a basis
- integrating commissioning and qualification efforts
- using .NET framework to minimize validation efforts, by ensuring functionality of applications once then deploying to various clients
In regards to managing the information and documentation, several additional practices are evolving:
- more structured documents upstream in the drug development cycle enable pertinent data to be easily imported into manufacturing systems – resulting in faster time to market
- the technology and ability to easily interface various systems in a manner that is maintainable is becoming a reality due to S95 and other standards; therefore, pharma manufacturers can readily produce a complete electronic batch records that include recipe, formulas, manual, and automated actions, comments, required data to be gathered during processing, prompts, alarms, deviations, signatures, approvals, etc.
- easily accessing current and approved reference documents (SOP, MSDS) for plant floor work instructions to ensure proper actions are taken
- verifying the training certification of operators at point of action
- managing documents throughout their life cycle: document check-in and check-out, version management, automatic routing, storage, single- and multi-document change control, archived records management, and printing
Helping process manufacturers solve these documentation, maintainability, training and change management challenges is simplified with software like Compliance Suite and project teams who can automate these manual processes.