Method Development, Qualification and Validation

ACP has the necessary equipment and experience to perform validations of analytical methods in any formulation. This valuable experience will reduce your development time required to get to a validated method. This in turn helps accelerate your product to the market place.

Our phase appropriate validation protocols are developed closely with the client’s goals in mind. ACP’s Standard Operating Procedures for these validation methods is modeled after the guidelines in USP chapter of Validation of Compendial Procedures <1225>. Evaluation of key parameters are essential to a robust validation. Accuracy, precision, specificity, detection limit, quantification limit, linearity, range and robustness are evaluated in each validation procedure.

Cleaning validations are also critical to remain in compliance, especially in a multi – product facility. ACP has years of experience in cleaning validation and can help on or off site for your projects. At completion of any campaign, cleaning verifications are performed on all major equipment to ensure the cleanliness and removal of any active ingredient or cleaning agent.

Whether you need validation for your API, in-process or drug product testing, ACP is here to provide valuable expertise for your project.

Method Development, Qualification and Validation by Alliance Contract Pharma

Why Choose Us

  • Experience – 100 years of combined experience in the pharmaceutical industry with an emphasis on contract manufacturing and laboratory services. We have manufactured and/or tested nearly every currently available pharmaceutical dosage form.
  • Quality – We have an unwavering commitment to providing quality service that exceeds our clients’ and regulators’ expectations.
  • Value – In these challenging economic times, you need to maximize the value of your projects more than ever. ACP will provide the highest value for your budget dollar.
  • Speed – ACP is ready to be of service today. Yes, there are larger CMOs, but with timelines short and budgets tight, speed is key. ACP will deliver on time, on-budget, every time.

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Our Vision

our vision

To be the leading customer focused service provider to the health care industry.

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Our Mission

our mission

Alliance Contract Pharma is a leader in providing value-added services to our customers by creating a successful partnership with them throughout their project. Our pledge is to establish lasting relationships with our customers by exceeding their expectations and gaining their trust through exceptional performance by every member of the ACP team.

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Our Values

our values

Our customers improve the quality and longevity of people’s lives. It is our privilege to contribute to this great mission.

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