Pharmaceuticals Biologicals Medical
Life Science manufacturers are continuously seeking ways to drive down costs and streamline operations while addressing mandates such as the FDA’s 21 CFR Part 11. Mergers, acquisitions and industry consolidations are a significant factor as manufacturers gain competitiveness through size and niche markets. Enterprise Business Systems for the Life Sciences Industry manage the critical information that drives business profitability concurrently ensuring product safety.
The life sciences industry includes companies that manufacture pharmaceuticals, nutriceuticals, biotechnology and medical devices. Companies in these industries develop, formulate, manufacture, package, label, store, and ship products intended for human or animal use. They face the same business drivers as other manufacturing industries with the added responsibility to abide by FDA (Food and Drug Administration), USDA (United States Department of Agriculture) or ICH (International Conference on Harmonization) regulations.
As pharma ERP experts, PSGi’s extensive experience working with companies that manufacture pharmaceuticals, nutriceuticals, and biotechnology products enables us to provide business process implementation and optimization services incorporating current Good Manufacturing Practices (cGMP) and other industry best practices. These services are targeted at maximizing the flow of critical information through the organization, minimizing redundancies and ensuring this information is used to make vital business decisions.
Critical in the implementation of enterprise business systems is the knowledge and experience to ensure that best practices are employed to achieve cGMP, Lean or JIT (Just-In-Time) practices. PSGi has the experience and know how to configure and implement these business systems, and concurrently implement the business processes to ensure the requirements are addressed.
Complexities of the life science manufacturing industry include these characteristics requiring constant flow of information:
- Compliance with government regulations such as 21 CFR Part 11 which includes secured master data management with Electronic Signatures recording who changed information and why
- Business system validation ensuring consistent data, security and processes are employed to consistently produce a product meeting specifications
- Drug manufacturers are required to serialize drug products at the item, case, and pallet level and be able to generate a “pedigree.”
- Contract manufacturing is becoming more prevalent in Life Sciences and business systems must be able to manage this trend
- Operations with variations in raw materials, formulations and packaging
- Recipes or formulas which may include by-products, co-products, intermediates, variations in expected yields and alternate equipment-specific formulas
- Inventory management that includes materials characteristics such as potency, catch weight, classifications, expiration dates, lot control, and varying units of measure
- Product recall reporting that necessitates bi-directional lot track and trace reporting from cradle to grave and back again
- Packaging phase-in and out is very important as product proliferation in packaging is an increasing trend that life science manufacturers have to manage
- Managing inventory levels, production schedules and yields, capacity loading and a variety of cost factors to maximize profitability
Managing this information well leads to:
- Operational excellence reducing waste, running more efficiently and maximizing utilization
- Enhanced and market aligned decision making
- Compliance with evolving USDA, FDA and ICH and other regulations
- Consistently producing the highest-quality products.
- Manufacturing agility enabling better reaction to opportunities and obstacles
- Managing profitability for greater business growth
- Competitive advantages