Global Quality Assurance and Regulatory Compliance: The Business Case for an Enterprise-Wide Strategy - A centralized quality control strategy may be the best solution. - BioPharm International

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Global Quality Assurance and Regulatory Compliance: The Business Case for an Enterprise-Wide Strategy
A centralized quality control strategy may be the best solution.


BioPharm International
Volume 21, Issue 11

Consistent Messaging and Common Nomenclature

Consistent messaging and common nomenclature are critical for any organization that has the following: dispersed facilities; employees of different cultures and language; a changing workforce with varying levels of skills, education, and industry experience; and a growing reliance on outside partners. The mergers and acquisitions commonplace in the industry during the past five years have further complicated the task of creating an enterprise-wide culture of quality and compliance.

For one company, a change in corporate ownership produced a significant challenge and an important response. The merger of two pharmaceutical firms was quickly followed by an acquisition by a third company. The resulting organization was immediately responsible for 50 plants around the world, more than 60,000 employees, and three distinct corporate cultures, each with its own policies, procedures, and philosophy. The new firm's response was to create an enterprise-wide culture built on quality and compliance. More than 70 standard operating procedures (SOPs) from the different companies were completely rewritten to create a single harmonized standard of quality for the new organization. The company developed an online training program that enabled global distribution of the new SOPs to more than 5,000 managers. Each manager was expected to set up meetings to review the documents and integrate their cultural messages communicating with employees about the new standards and expectations. This year-long initiative produced an organization with a cohesive, reinvigorated workforce that shared a common culture, heard the same messages, and performed to the same standards.

Certifications of Employees and Subcontractors

Optimum performance requires the demonstrated competency of employees, subcontractors, and suppliers. To ensure that competency, a company must follow a multistep process of initial assessment to accurately identify knowledge gaps and competency levels, develop role-based curricula, and target distribution of relevant training materials, testing for comprehension, and certification of the qualifications necessary for specific job functions.

With the goal of reducing human error and assuring compliance with corporate standards and regulatory requirements, a biopharmaceutical company has developed a unique online operator certification solution that integrates training with the company's manufacturing execution system (MES). System parameters are set to recognize whether operators have completed training and met defined proficiency thresholds. If not, the system denies equipment access to those individuals.

Enterprise-Wide Training

For an enterprise with dispersed facilities and personnel of different cultures and languages, online training as part of a blended learning program is virtually indispensable in assuring consistency of knowledge throughout the organization. The term training is typically associated with skills training. However, it also applies to a range of educational needs that are likely to confront any organization. These needs may involve issues as diverse as SOPs, regulatory updates, equipment operations, and non-GMP requirements such as sexual harassment and facility security.

Failure to follow established SOPs is one of the most frequently cited violations in FDA 483s and warning letters. The frequency of SOP-related violations points to the need for all regulated companies to review their SOPs, their methods for distributing compliant SOP training curricula, their methods of validating receipt and testing for comprehension of the materials, and their documentation of SOP training activities. Additionally, enterprise-wide training programs must include automated methods for new employee onboarding, and for annual refresher training.

Centralized Documentation and Distribution

Centralized documentation organized in an audit-ready format enables rapid access to requested data by regulatory inspectors. It also minimizes the risk of lost, unavailable, or incomplete records. This centralized documentation and distribution is especially important for regulatory updates. As regulations change—and they do so with great frequency—it is critical that the changes be disseminated to those people whose work will be affected. It is also vital that changes be accurately validated and documented, particularly in a company with dispersed facilities and partners. A company cannot afford to base its product quality and regulatory compliance on a system that is vulnerable to the limitations of paper-based records, illegible signatures, and lost validations.

Vendor Certification

With regulatory attention now focusing on CMOs and other suppliers, some sponsoring companies require contractors to adhere to the same quality and compliance systems as those implemented for employees. By promoting the use of common training curricula, distribution, and tracking systems with audit-ready documentation, the sponsoring company supports a seamless extension of its own activities, thereby minimizing risk. Equally important is a centralized database that confirms vendor qualifications, because such information can assure any facility in the enterprise that a given vendor has been adequately vetted.


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