PIC/S GMP Annex 16 newly established

PIC/S GMP Annex 16 newly established

Until now, PIC/S GMP Annex 16 has been absent. The reason is that EU GMP Annex 16 is a Qualified Person (QP); QP is a special European qualification requirement and has not been applied to other PIC/S member states.

On February 1, 2022, the PIC/S Guide was revised and Annex 16 “CERTIFICATION BY THE AUTHORISED PERSON AND BATCH RELEASE” was established.

PIC/S expects Annex 16 to be adopted in each country. However, Annex 16 has not yet been issued in Japan.

Under the GMP Ministerial Ordinance and QMS Ministerial Ordinance in Japan, a shipping decision must be made when products are shipped to the market.
In the shipment decision, records of manufacturing and quality tests are checked by the quality assurance department before shipment is approved.
However. In many cases in Japanese companies, if there are no deficiencies in the manufacturing or quality test records, the shipment is stamped (or signed) as is.
Such a simple method can be done by part-time staff or part-time workers.

Essentially, the shipment decision is made by a third party, such as the quality assurance department, who again thoroughly examines the records of manufacturing and quality testing, and approves the shipment if there is absolutely no doubt about it.
In the course of his work, the author sometimes goes to overseas companies to conduct audits.
In Europe, only Qualified Persons (QP: Authorised Persons in PIC/S member countries outside Europe) may authorize shipments.
Even if a manager or plant manager is not qualified as a QP, he or she may not approve shipments.

In many European pharmaceutical companies, the QP has four or five subordinates thoroughly examine all manufacturing and quality records.
Moreover, they have them double-checked.
Manufacturing records include validation records, etc. Quality test records include sampling records, etc.
Naturally, transcription errors, description errors, and calculation errors are also checked.

In particular, records of changes in raw data must be rigorously checked.
In the case of electronic records, it is important to verify the audit trail.
Other references may include reagent control status, calibration records, and education and training records, as needed.
Finally, when the QP is confident of the quality of the product in question, he or she approves the shipment.

PIC/S GMP Annex 11 Computerised Systems, published on January 1, 2013, states the following

15.Batch release
If a computerized system is used to record approvals and batch releases If a computerized system is used to record approvals and batch releases, the system must allow only Authorised Persons to approve batch releases and must clearly record who released the batch, i.e. who approved it.
Electronic signatures must be used for such work.

The name of the QP(AP) who approved the shipment must be clearly recorded for each batch.
Once the QP(AP) approves a shipment, the shipment judge is responsible for it, even if the manufacturing or quality department made a mistake.
The reason why electronic signatures must be used here is that electronic signatures cannot be backdated. (since handwritten signatures can be dated arbitrarily)
In addition, Annex 11 has the following requirements

8.1 For data stored electronically, a clearly printed copy must be available for output.
8.2 For records supporting batch releases, it must be possible to generate a printout indicating whether the data has changed since the original entry.
Electronically stored data includes not only raw data but also metadata such as audit trails.

Records supporting batch releases (shipments) (i.e., manufacturing and quality test records) must be available to verify whether they have changed since the initial entry.
In other words, the audit trail must be printable.
This is because quality assurance departments, auditors, and inspectors from the authorities need to check the audit trail.
In other words, a mechanism to detect tampering is needed.

21 CFR Part 11 Electronic Records, Electronic Singature, which went into effect in August 1997, states the following

Use equipment checks (such as terminal equipment) to determine the validity of the basis for data entry and operation instructions, as appropriate.

This requirement is difficult to understand and ambiguous in meaning, and few people understand it correctly.
This requirement is to ensure that the information is entered from the correct terminal (i.e., the correct person) and that unauthorized persons do not make shipping decisions, for example.
The author had the opportunity to speak with a former head of quality assurance at a pharmaceutical company who had once been in charge of shipping decisions for many years.
He says that when he retired, he could finally sleep peacefully.
This is because they feel responsible if the quality of the product they have approved for shipment has some problem and causes a health hazard to patients.

Many pharmaceutical and medical device companies are well aware of the purpose of the shipping decision and wish to see their records thoroughly checked from the patient’s perspective before they are shipped.

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