Quality assurance
POPs, records and licenses kept up to date, with alerts before each deadline.
Each branch’s Good Practices Manual, POPs (standard operating procedures), records and licenses live in one place, with their version and expiration date. Beatriz, an AI agent, organizes the documents and alerts you before each review and each expiration; the responsible pharmacist approves each POP.
Illustrative example.
The module agent
Beatriz organizes and alerts. The pharmacist approves.
Beatriz Lima keeps every quality document with its current version and history, tracks each POP’s review and each license’s expiration date, and alerts you ahead of time. She prepares the review draft from the current version. The responsible pharmacist approves each POP, and the person accountable for quality closes each nonconformity.
Keeps every quality document with the current version, who approved it and the history
Tracks each POP’s review and each license’s expiration date, and alerts you before the deadline
Prepares the review draft and the list of people who need training on the new version
Records self-inspections, nonconformities and corrective actions, with the deadline and the person responsible
What expires at the Downtown Branch in the next 90 days?
Three deadlines. The health license expires in 60 days, and the alert has already gone to the person accountable for quality, along with the branch documents already in the system. The weighing POP is due for its annual review in 3 weeks: I prepared the draft of version 5, which is awaiting the responsible pharmacist’s approval, and the list of the 6 bench staff who will be trained on it. The calibration of the two scales expires in 75 days.
Illustrative example.
Quality documents
Manual, POPs and records, with versions and approvals.
The pharmacy’s Good Compounding Practices Manual, POPs, specifications, forms and records live in one place, by branch. Each document has its current version, who wrote it, the responsible pharmacist’s dated approval and the history of previous versions.
The team sees only the current version; previous ones stay in the history, never deleted
Each POP is reviewed at the interval the pharmacy sets, such as once a year, and the alert arrives before the deadline
A new version takes effect only with the responsible pharmacist’s approval
Correcting a record keeps what was written before, with the reason and who corrected it
Day-to-day records, such as cleaning and temperature, stay linked to the POP that requires them
Illustrative example.
Licenses and certificates
Each branch’s licenses, with alerts before they expire.
Each branch has its own licenses and certificates, with the issuing agency, number, issue date and expiration date. Validity depends on each document, for example annual or every two years, according to the agency and the municipality, and some documents don’t expire. Beatriz sends alerts 90, 60 and 30 days ahead, or on the schedule the pharmacy chooses.
Health license from the state or municipal health surveillance authority
Anvisa operating authorization and, for pharmacies that compound controlled substances, the special authorization
CRF certificate of good standing, with each branch’s responsible pharmacist
City business permit and the Fire Department certificate, such as the AVCB or CLCB
Polícia Federal licenses and MAPA registration, when the branch needs them
Illustrative example.
Quality routine
Training, self-inspection and equipment, with records and deadlines.
Training on POPs
Each training session is recorded with the content, date, hours, who attended and who led it, along with the effectiveness assessment. When a POP changes, Beatriz lists who needs to be retrained.
Self-inspection
Self-inspection is done at least once a year, as RDC 67/2007 requires, under the pharmacist’s supervision. The checklist of good practices items is in the system, the conclusions are kept, and each finding becomes a corrective action with a deadline and an owner.
Nonconformities and complaints
A deviation at the bench or a self-inspection finding becomes a nonconformity, with the investigation, the corrective action and the deadline. A customer complaint is recorded with the patient, the formula and the reason, and the investigation is up to the pharmacist.
Equipment
Calibration of the scales and other instruments by a certified company, at least once a year or depending on use, is recorded with the certificate and the next due date. The daily check, before work begins, is recorded too.
Pests and water
Integrated pest control, applied by a licensed company, and water tank cleaning are recorded with the next due date. Drinking water testing, at least every six months, and purified water testing, at least once a month, come with alerts before the deadline.
Certificates of analysis and suppliers
The certificate of analysis for each raw-material lot stays linked to the lot, in inventory, and each supplier’s qualification, in purchasing. Self-inspection uses both.
What stays with people
Beatriz organizes and alerts. People approve and close.
01
Approve each POP
The responsible pharmacist approves each POP and each revision. Without approval, the new version doesn’t take effect, and the previous one stays valid.
02
Close the nonconformity
The person accountable for quality defines the corrective action, checks whether it worked and closes each nonconformity. For a customer complaint, the investigation and corrective measures are up to the pharmacist. Beatriz records and tracks the deadline.
03
Renew licenses
The pharmacy renews each license with the issuing agency. Beatriz alerts you before the deadline and gathers the documents already in the system; she doesn’t submit anything to the agencies.
Questions about quality assurance.
See a branch’s quality assurance.
In the demo, you see a POP with its version and history, an alert for a license about to expire and a nonconformity from opening to closing. We handle the pharmacy’s migration at no cost.