Pharmaceutical Compliance Guide
The "Seamless Lab Compliance for Pharmaceutical Manufacturers" guide discusses strategies and solutions to help pharmaceutical laboratories with compliance.
A robust understanding and efficient approach to regulations and life cycle management are essential for pharmaceutical manufacturers. Our Seamless Lab Compliance guide shows how your pharmaceutical laboratory can benefit from our state-of-the-art portfolio. Our products, services, and solutions have been specifically developed to support your compliance with regulations. We aim to assist you in developing and implementing internal controls and procedures.
Develop Lean and Effective Compliance Systems
According to the World Health Organization, 124 countries have pharmaceutical production capabilities. Regardless of where a drug is manufactured, each medicine must comply with stringent international regulations to ensure safety and efficacy.
The updated Seamless Lab Compliance for Pharmaceutical Manufacturers guide highlights products and solutions that were particularly developed to help pharmaceutical laboratories with compliance.
The Seamless Lab Compliance for Pharmaceutical Manufacturers Guide Covers:
- Solutions supporting the fulfillment of GMP and pharmacopeia standards
- A concept for efficient data management with special focus on data integrity
- Products with features and user management that help the user to achieve compliance and adherence to SOPs
- Advice on how analytical instruments and weighing systems should be selected, installed, and verified
- Service solutions to enhance product quality and regulatory compliance
- Guidelines to establish efficient life cycle management
What is compliance in the pharmaceutical industry?
The pharmaceutical industry is highly regulated. National and international standards and regulations, such as Good Manufacturing Practice (GMP), are becoming increasingly important, if not a prerequisite for conducting business. Companies are allocating significant resources to ensure regulations are implemented and processes are validated. As the pharmaceutical industry is overloaded with regulatory documents and working practices it needs a robust and effective model to drive compliance.
What are the benefits of compliance in the pharmaceutical industry?
"The OIG believes a comprehensive compliance program provides a mechanism that addresses the public and private sectors’ mutual goals of reducing fraud and abuse; enhancing health care provider operational functions; improving the quality of health care services; and reducing the cost of health care. Attaining these goals provides positive results to the pharmaceutical manufacturer, the government, and individual citizens alike.
"In addition to fulfilling its legal duty to avoid submitting false or inaccurate pricing or rebate information to any federal health care program or engaging in illegal marketing activities, a pharmaceutical manufacturer may gain important additional benefits by voluntarily implementing a compliance program. The benefits may include:
- A concrete demonstration to employees and the community at large of the company's commitment to honest and responsible corporate conduct;
- An increased likelihood of preventing, or at least identifying, and correcting, unlawful and unethical behavior at an early stage;
- A mechanism to encourage employees to report potential problems and allow for appropriate internal inquiry and corrective action; and
- Through early detection and reporting, minimizing any financial loss to the government and any corresponding financial loss to the company. "
(OIG, Compliance Program Guidance for Pharmaceutical Manufacturers, 2003)