The purpose of this Quality Agreement is to establish, clarify and communicate quality expectations between Front Range Laboratories, hereafter referred to as “FRL” and our clients, hereafter referred to as “the client”.
This agreement is for all samples submitted to FRL related to the manufacture of pharmaceutical products whether from a compounding pharmacy, an outsource facility or a cGMP manufacturer. In the case where a separate quality agreement is signed between FRL and the client, the client specific quality agreement supersedes this general quality agreement. We recommend that clients generate their own quality agreement with FRL.
By submitting samples to Front Range Laboratories the client agrees to this Quality Agreement. The effective date of this agreement is the date the client sends their first sample to FRL. This agreement is in affect throughout the duration of the business relationship between FRL and the Client
Payment for Services
1. Submission of sample constitutes a contracting of FRL’s services. Clients are responsible for requesting prices and quotations.
2. FRL reserves the right to modify pricing, pricing structures, and any discounts without prior notice.
3. Payment is expected upon completion of services. Services are complete upon issuance of testing results by FRL to the Client.
4. Payment terms are fifteen (15) days net. The past due balance shall be subject to late charges not to exceed 1-1/2% per month, or the highest rate allowed by law, whichever is less. Client shall be liable for all costs incurred in collection of past due balances including but not limited to collection fees, attorneys’ fees, filing fees and court costs.
5. Payment may be made by credit card (Amex, Visa, MC), Business Check or ACH/EFT.
Quality Unit Responsibilities
1. The client is responsible for assuring that the pharmaceutical products they produce meet all applicable laws, regulations and standards.
2. The client is fully responsible for final product approval or rejection decisions. Test data supplied by FRL is not sufficient to make a decision on the release of pharmaceutical products for distribution. The client is ultimately responsible for assuring the identity, strength, quality, purity and safety of their products. FRL makes no claim to serve as the client’s quality unit.
3. The client is responsible for selecting appropriate samples and quantities for analysis and for ensuring that the sampling process is based on applicable laws, regulations and standards. This includes ensuring appropriate sampling plans per applicable standards.
4. The client is responsible for determining sample and or product specifications if different from USP. Results to be report to a specific compendial chapter in USP must meet sampling requirements and have undergone appropriate validations, verifications, and/or suitability studies.
5. The client is responsible for trending product test results and for defining unacceptable trends.
6. The client will advise FRL of any knowledge concerning sample instability and/or prior test results that might impact the storage, handling and/or testing of the client’s samples.
7. The client is responsible for the control and review of any services requested from FRL. With prior notification and during normal business hours, FRL shall allow the client or an approved client affiliate, reasonable access to the facility, appropriate personnel (numbering up to three members) and relevant documents. FRL reserves the right to redact information and data containing other clients’ information. The client may not publicly publish the results of the audit. FRL will respond to all concerns as the result of a client audit within sixty days.
Facilities and Equipment
1. FRL will maintain sufficient premises, equipment, processes, procedures and supplies to carry out testing of samples.
1. FRL will test samples in accordance with applicable industry practice standards, cGMP and/or USP. Testing activities will be fully documented in such a way to provide traceability.
2. FRL will ensure that personnel performing and reviewing testing have the necessary education, experience and training.
3. FRL will validate non-compendia methods and utilize USP standards or show equivalency for these methods and standards for cGMP testing.
4. The client is responsible for completing FRL’s sample submission form with the samples to be tested. The client must provide accurate information relating to the samples to be tested and what testing is to be performed.
5. The client is responsible for submitting reserve samples if necessary. If these samples are stored at FRL, the client will communicate the proper storage requirements.
6. The client is responsible for the safe and secure shipment of samples in order to maintain sample quality and integrity prior to arrival at FRL. This includes ensuring all proper shipping conditions, such as temperature, light exposure and humidity, are met.
7. FRL will perform testing as requested by the client and will apply specifications agreed upon with client.
8. FRL will perform testing as an independent contractor and the client will have no control over FRL’s employees and agents.
9. FRL shall notify the client of any confirmed Non-Conforming Results (NCRs) in a timely manner and to perform an investigation in accordance with FRL’s internal procedures. The client is responsible for performing their own investigation.
10. FRL shall notify the client of any non-conformance or deviation identified that may impact the quality of the data generated by FRL for the client within 48 hours.
11. FRL shall maintain all dilutions, sample prep, and initial starting analytical material/standards in appropriate storage conditions for FRL investigative purposes until it is determined by FRL that analytical results are acceptable.
1. FRL shall maintain all test data generated by FRL. Original observations will be recorded in bound laboratory notebooks or on controlled data collection forms. All data relating to the client’s samples shall be made available to the client for review upon request, however information pertaining to other client data will be redacted.
2. FRL will retain records for five years beyond the date of testing for each sample. If this retention time is deemed insufficient, the client is responsible for contacting FRL to arrange for the recovery of records prior to the five year time point. After five years, sample test records will be destroyed.
3. FRL is not responsible for client’s data retention. While records will be kept as per FRL Retention policies and made available, Clients are responsible for their own record retention obligations.
4. Access to records once a client is no longer a client of FRL will be made available to the client in a timely matter for a per document fee.
1. FRL shall maintain a change management system including a work order system, deviation system, corrective/preventive action system and document control system.
1. FRL will not divulge client’s proprietary information such as formulations.
2. FRL will only release data to authorized agents within the client’s organization.
3. FRL may disclose client information to regulatory agencies as required by law.
Any dispute regarding this quality agreement will be discussed between FRL and the client.