Many life sciences and manufacturing companies find it advantageous to outsource some of their functions to contract manufacturers, testing laboratories, and research organizations. Outsourcing allows companies to concentrate on their core competencies and at the same time reduce labor and overhead costs. OEMs are demanding faster turnaround times and more advice, and contract research, testing and manufacturing providers must deliver. In addition, current consumer worries about medical product and food safety hazards have made an impact on contract organizations, which are experiencing an increase in scrutiny by clients and regulators.
Contract Research Organizations (CROs)
The most important challenges facing the CRO industry are strict regulatory requirements and pharmaceutical consolidation. Worldwide regulatory bodies increasingly require more detailed safety control of drug candidates to ensure safety of final products and avoid potential product recalls. In order to comply with these regulations, CROs must generate more carefully designed studies, which can only be achieved using scientific teams of great expertise in specific therapeutic areas and high-level quality of research and services.
As companies look at outsourcing, there's a certain perceived risk in taking a molecule or a process out of house to be developed by a contract lab. The greatest challenge is loss of control. However, the contract lab may have the experience, resources, equipment, etc., that could be prohibitively costly to secure, and also free up the sponsor to focus on core competencies. Contract laboratories to secure growing projects need to show the “5Cs” — competency, capability, commitment, cost and compliance. Labs not only need to demonstrate experience, instrumental capabilities, and knowledge of key personnel relevant to the project, but also their approach and commitment to quality and some certifiable level of compliance. All this must be accomplished while providing superior customer service.
Current consumer worries about food safety have made an impact on contract analytical laboratories for food chemistry testing, which are experiencing an increase in inquiries and sample volume. Media exposure of potential hazards has also become a challenge, as seen by such recalls as pet food, spinach, peanuts, and milk with melamine. The challenge for both routine and non-routine contract analytical testing laboratories is to stay abreast of the issues affecting the industry. Also important is balancing the need for high quality, reliable data, and interpretations with the quest for timeliness and low cost.
Contract Manufacturers (CMOs)
A CMO's entire business depends on the strength of its quality systems, and faces three main challenges. First, it is important not only to understand the current industry and international regulations, but also to anticipate and plan for the continuous raising of the compliance bar by regulatory organizations. CMOs must not only look at how regulations affect their global quality systems, but how the regulations may individually impact their customers’ products. The key to overcoming this obstacle is to take an aggressive and forward-looking approach to the ever-changing regulatory environment in which CMOs work.
The second challenge is managing the CMO's customers’ quality expectations. Typically, each customer has a slightly different approach to quality requirements for their products. It is crucial as a contract manufacturer that the needs of the customer are addressed and at the same time maintain complete control over the quality systems.
Finally, CMOs must harmonize their regulatory framework, individual customer requirements and their quality systems so that they ensure not only compliance but also consistency in standard operating procedures (SOPs). The key to overcoming this obstacle is having a foundation of SOPs providing a solid and consistent framework from which employees can address any and all compliance issues.
Pilgrim equips its customers to meet three major challenges. With Pilgrim’s solution you:
Ensure Regulatory Compliance
When a company transfers a function to a contract organization, the CxO becomes subject to the same regulatory action as its client. Contract organizations share with their customers the burden of compliance. Regulatory requirements include ISO 9001, ISO 17025, other ISO standards, FDA 21 CFR Part 11, Part 820, 210-211, GMP, GCP, GLP, and other national and state regulations for product safety, and more.
Pilgrim’s solution helps ensure compliance with these regulations, thereby minimizing risk, avoiding the potential for costly recalls, and securing brand reputation. Its pre-built tools enable electronic signatures and automate regulatory recordkeeping, and help your company conduct safety and compliance monitoring by establishing flexible, global workflows for product complaint resolution, nonconformance, CAPAs and audits.
Homegrown, non-integrated and manual management systems require paper-and labor-intensive processes and result in a lack of data visibility across the organization and the ease to communicate with the OEM. Impacts include higher IT administrative and overhead costs, less IT productivity and ineffective resource utilization.
Pilgrim’s solution integrates people, processes, products/services and systems under one automated enterprise solution. This provides for timely data across the company and reports back to the OEM, reduces risk, and reduces the labor requirements by eliminating paper-intensive processes, and lowers administrative and overhead cost.
Improve Efficiencies and Boost Productivity
Contract Services organizations are pressured to do more with less. Companies are falling victim to the time and cost of handling documents, identifying and resolving problems in product development and testing, managing supplier quality, maintaining equipment and ensuring a trained workforce.
Pilgrim’s solution interfaces with a company’s internal systems (including ERP/MRP, MES, HR, PLM and PDM), to ensure that compliance and quality are part of the entire product lifecycle and service delivery management. The result is streamlined decision making, lowered costs for bringing products to market, the elimination of product stalls, and the delivery of higher quality products.