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Mind your QAPs The Quality Assurance Person plays a vital role in your company’s quality operations. Above all, the primary responsibility of your QAP is to assure the quality of your facilities through the implementation and maintenance of Good Manufacturing Practices (GMPs). Not just anybody can be a QAP. To be capable of carrying out all the necessary quality-related functions, the QAP should have relevant training, experience and technical knowledge. Why is it so important that they be qualified as such? It is important because the consumer is placing a great deal of confidence in your product, and as a result, only a professional with the appropriate background can safely guarantee the quality of your product(s) and operations. If you do not currently have a qualified QAP, you may wish to consider acquiring the services of a third-party consultant to handle your quality assurance functions. However, bear in mind that you must ensure that they also satisfy the above training, experience and technical knowledge requirements. The QAP's responsibilities also include:
1. Approval of:
* Raw and packaging materials
2. Conducting self-inspections for compliance against GMPs
* Finished product prior to sale * Returned goods prior to resale, and Standard operating procedures (SOPs) prior to their implementation. 3. Ensuring that foreign site manufacturer(s) are GMP compliant 4. Investigation and reporting of consumer complaints The NHPD assesses the qualifications of your QAP based on the information provided in the Quality Assurance Person Qualification Form (QAPQF). Attached to the QAPQF should be documentation supporting the QAPs education, training and experience. For a listing of minimum recommended qualifications please refer to Chapter 3, Table 2 of the Good Manufacturing Practices Guidance Document (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/gmp-bpf_e.html#3). The ultimate goal is to provide a product that is safe, effective and of high quality, and the first step towards this objective is to have a competent QAP overseeing all operations. Remember, quality is your best mark. Not only does it establish confidence with both foreign and domestic regulators, but also with your consumers. Common Errors and Deficiencies relating to QAPs The following is information on the common errors and deficiencies found in site licence applications sent to the NHPD. These errors, though they may seem minor in some cases, can lead to major time delays and can be easily avoided if applicants take the time to properly prepare and review their applications before submitting them to the NHPD. Looking specifically at the Quality Assurance Person Qualification Forms (QAPQF) received to date, the most common deficiencies have been:
1. No GMP knowledge or training
2. Lack of experience relevant to the activity conducted 3. Lack of documentation to support qualifications Ideal submissions received by the NHPD have the following:
1. A qualified QAP that can demonstrate an effective quality assurance program is in place at their site(s)
2. A QAP that has the relevant experience to the activity conducted 3. Supporting QAP documentation (i.e. diplomas, certificates, CV/resume). To expedite the assessment of site licence submission, the SLACCD asks that applicants include relevant information within the answer space of all Quality Assurance Report (QAR) fields. All supporting documentation and records should be referenced to the appropriate field. The goal is to provide the assessor with an overall picture of your operation and eliminate the need to request additional information. |