In many compounding pharmacies, quality assurance lives in three places: a binder of printed POPs (standard operating procedures), a spreadsheet of license expiration dates and the memory of whoever has looked after it for years. It works until the binder holds two versions of the same POP or that person goes on vacation.
This guide sums up what Anvisa’s RDC 67/2007 requires, how to keep POP reviews and each branch’s licenses up to date and who decides what.
What RDC 67/2007 requires
RDC 67/2007 remains in force, with amendments. Annex I requires the pharmacy to have a Quality Assurance System that is fully documented and monitored. In practice, that covers five areas:
- Documentation. A Good Compounding Practices Manual and written procedures for operations. Documents are approved, signed and dated by the responsible pharmacist or by a person they authorize, and any change leaves the original text visible and, where applicable, the reason for it.
- Approved, up-to-date POPs. It is up to the pharmacist to approve the compounding procedures and update them regularly.
- Training. The whole team takes part in a training program. The record includes the activities, the date, the number of hours, the content, who took part, with signatures, and who gave the training. The effectiveness of each training session must be assessed.
- Self-inspection. At least once a year, with the conclusions documented and filed. The findings become corrective actions.
- Complaints. Each complaint about a quality defect is recorded with the patient’s and the prescriber’s details, the product, the formula number in the prescription book, the nature of the complaint and who made it. The pharmacist investigates, takes corrective action and gets back to the person who complained.
POP review: the regulation does not set the interval
RDC 67/2007 does not define how often each POP must be reviewed. It requires the pharmacist to update the guidelines and procedures regularly. The interval is the pharmacy’s decision, for example once a year.
The hard part is knowing which version is in force, who has already been trained on it and when the next review is due. In VUpharma’s quality assurance, each POP has its current version, who drafted it, the responsible pharmacist’s approval, with the date, and the history of previous versions, never erased.
By default, Beatriz, the quality AI agent, sends an alert 30 days before the review. She prepares the draft of the new version from the one in force and the list of people who need to be trained on it. The new version only takes effect with the pharmacist’s approval; until then, the previous one remains in force.
Licenses and certificates, branch by branch
Each branch has its own licenses, each with its own issuing authority and validity period:
- Health license, from the state or municipal health surveillance authority.
- Anvisa operating authorization and, for pharmacies that compound controlled substances, the special authorization.
- CRF (Regional Pharmacy Council) certificate of good standing, with the branch’s responsible pharmacist.
- City business permit and Fire Department certificate, such as the AVCB or CLCB.
- Polícia Federal (Federal Police) licenses and MAPA (Ministry of Agriculture) registration, when the branch needs them.
There is no single deadline. Validity depends on each document, for example one year or two, depending on the authority and the municipality, and some documents do not expire. Anvisa’s operating authorization, for example, no longer needs to be renewed since Lei 13.043/2014. The Polícia Federal operating license for businesses that work with controlled chemical products, on the other hand, is renewed every year, and the application is filed in the last 60 days of validity.
That is why the alert needs to arrive before the renewal window. In VUpharma, each document has its issuing authority, number, issue date and expiration date, and Beatriz sends alerts 90, 60 and 30 days ahead, or at the intervals the pharmacy chooses. She gathers the branch documents already in the system. The pharmacy handles the renewal with each authority: Beatriz does not send anything to any authority. See also the health-regulatory dossier for each branch.
Equipment calibration and maintenance
The regulation requires calibration by a certified company, with standards traceable to the Rede Brasileira de Calibração (Brazilian Calibration Network), at least once a year or according to frequency of use, with records. Verification is done by trained pharmacy staff before the day’s work begins, also with records. And all equipment undergoes preventive maintenance under a formal program.
In VUpharma, each scale and each instrument has the certificate from its latest calibration, the date of the next one and the daily verification record, with an alert before it falls due.
Certificates of analysis and qualified suppliers
The regulation also requires raw materials to be bought from a qualified manufacturer or supplier and each lot to arrive with the supplier’s certificate of analysis. Qualification takes into account health-regulatory compliance, tests and certificates, audits and delivery history.
In VUpharma, the certificate of analysis is linked to the lot, in inventory, and each supplier’s qualification is in purchasing. When self-inspection comes around, both are already at hand.
Who decides
The AI agents prepare; people decide:
- The responsible pharmacist approves each POP and each review. The regulation also allows a person they authorize; in VUpharma, POP approval stays with the responsible pharmacist.
- The person accountable for quality closes each nonconformity, after defining the corrective action and checking that it worked. In a customer complaint, the investigation and the corrective measures are the pharmacist’s.
- The pharmacy renews the licenses with each authority.
Beatriz records, organizes and tracks deadlines. She does not approve, close or submit. Meet VUpharma’s AI agents.
Moving off the spreadsheet
- List each branch’s licenses and certificates, with the issuing authority, number, issue date and expiration date.
- Set aside the Good Practices Manual and the POPs in force, with the date of their last approval.
- Define the review interval for each POP.
- Gather the calibration certificates, the training records and the report from the last self-inspection.
We migrate the pharmacy’s Manual, POPs and records at no cost, and you review them before going live. See how we migrate or request a demo to see a POP with its version and history and the alert for a license about to expire.
