Compliance to Brazil GMP requirements?

SGquality

Quite Involved in Discussions
#1
Can I get your thoughts on how to proceed for getting compliant to ANVISA Brazil GMP requirements?

We have a quality system complaint to ISO 13485:2016 and 21 CFR Part 820 so what needs to be done to show compliance to ANVISA requirements - being a contract manufacturer, do we just show compliance to the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013)?

Thank you!
 

AnaMariaVR2

Quite Involved in Discussions
#2
if your documented quality management system will do its job during an ANVISA audit, then clear
:agree: communication must be critical to its outcome to avoid unnecessary language barrier issues.
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#3
If you are a contract manufacturer, your contractor should be the ones requiring your compliance and clearly defining what you have to comply with.

But yes, you do need to show compliance with the ANVISA RDC 16/2013.

ISO 13485:2016 is much more in line with RDC 16/2013, but there's still some differences. You might USE the MDSAp audit model document to see which additional requirements you must fulfill.
 

Sam Lazzara

Quite Involved in Discussions
#4
I recently updated my quality system for Brazil compliance. Please keep in mind that my system addresses the comprehensive role played by legal device manufacturers.

High level steps were as follows:

1. Studied all Brazil medical device regulations, not just RDC 16/2013, to determine regulatory requirements applicable to the legal manufacturer role. The MDSAP G0002.1004 Companion Document and Emergo website are good resources for this step, in addition to the ANVISA website.

2. Wrote a Quality Plan that included a gap analysis (impact assessment) in which each Level 1 (Quality Manual) and Level 2 (SOP) document was assessed vs the Brazil requirements.

3. Implemented the Quality Plan. A summary of the changes is shown below.

Quality Manual
2.1 Applicable Documents, External Documents – Added Brazil regulations.
10.6 Brazil RDC 16 versus Quality System Documents – New cross-reference section added.

Quality System Glossary
Added Brazil regulations and associated terms.

Document Change Order (form)
Added “Brazil ANVISA” to RA Impact Analysis section.

Product Complaints SOP
Added section for Reporting of Post-Market Adverse Events to Brazil. Updated hyperlinks in Europe section.

Product Compaint Report (form)
Added Brazil Reporting Analysis section.

Post Market Surveillance SOP
Added Brazil to Regulatory Authority Reporting Requirements section (vis a vis recalls).

Regulatory Requirements and Compliance SOP
Added Brazil regulations and requirements.

There are only a few unique requirements in the Brazil RDC16 GMP as compared to ISO 13485 and FDA 21 CFR 820. Here are some notes I had handy - not sure this is a comprehensive listing.
- chemical waste disposal must be addressed
- purchase orders require signature approval
- analytical methods require validation
- nonconforming product documentation must include risk assessment to support product disposition
- CAPA, explicit mention of determining need for product recall and other field actions

BTW, as I recall, the RDC16 signature requirements are aligned with FDA 820 signature requirements. ISO 13485 does not require signatures. My system already addressed 820 requirements so other than the requirement for purchase order signatures I was fine. In general, I would say the the Brazil GMP is more aligned with FDA 820 than it is with 13485.
 

mare1

Starting to get Involved
#5
Dear all,

in our company we had MDSAP audit. Auditor checked our special processes in production which are subjects of walidation. He checked Device history records and he realized that there is no parameters or reference to parameters of special processes. He was referencing to the ANVISA RESOLUTION - RDC No.16 OF MARCH 28, 2013 (please see below). According to this statement, it was a nonconformity.
Auditor claimed that the parameters (temperature, humidity, time,...) of special processes (gluing, welding,soldering, cleaning S,...) for each component shall be written OR referenced in the DHR.
What do you think about it? Do you understand this as a reference to the parameters in the validation for each proces, or do you understand this that each operator will have to record the parameters each time he performs an action and this record should be referenced in the DHR even if the process is validated and equipment is calibrated?

ANVISA RDC statement:
3.2.1. Each manufacturer shall maintain device history records. Each manufacturer shall establish and maintain procedures to ensure that the device history records are kept for each batch or series to demonstrate the products were manufactured according to the device master record and the requirements of this Technical Regulation. The device history record shall contain or make reference to the following information:
3.2.1.1. Manufacture Date;
3.2.1.2. Components used;
3.2.1.3. Quantity manufactured;
3.2.1.4. Results of tests and inspections;
3.2.1.5. Special processes parameters;
3.2.1.6. Quantity released for distribution;
3.2.1.7. Labeling;
3.2.1.8. Identification of serial number or batch of the device; and
3.2.1.9. final release of the device.

Thank you very much,

Best regards
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#6
Dear all,

in our company we had MDSAP audit. Auditor checked our special processes in production which are subjects of walidation. He checked Device history records and he realized that there is no parameters or reference to parameters of special processes. He was referencing to the ANVISA RESOLUTION - RDC No.16 OF MARCH 28, 2013 (please see below). According to this statement, it was a nonconformity.
Auditor claimed that the parameters (temperature, humidity, time,...) of special processes (gluing, welding,soldering, cleaning S,...) for each component shall be written OR referenced in the DHR.
What do you think about it? Do you understand this as a reference to the parameters in the validation for each proces, or do you understand this that each operator will have to record the parameters each time he performs an action and this record should be referenced in the DHR even if the process is validated and equipment is calibrated?

ANVISA RDC statement:
3.2.1. Each manufacturer shall maintain device history records. Each manufacturer shall establish and maintain procedures to ensure that the device history records are kept for each batch or series to demonstrate the products were manufactured according to the device master record and the requirements of this Technical Regulation. The device history record shall contain or make reference to the following information:
3.2.1.1. Manufacture Date;
3.2.1.2. Components used;
3.2.1.3. Quantity manufactured;
3.2.1.4. Results of tests and inspections;
3.2.1.5. Special processes parameters;
3.2.1.6. Quantity released for distribution;
3.2.1.7. Labeling;
3.2.1.8. Identification of serial number or batch of the device; and
3.2.1.9. final release of the device.

Thank you very much,

Best regards
You need to record and reference the parameters in the DHR, even if the process is validated (otherwise, there would be no need to mention the special processes in the DHF requirement, as special processes already need validation).
 

mare1

Starting to get Involved
#7
Thank you for your prompt feedback.

For example - in gluing process, there are two parameters that need to be recorded - temperature and time of drying.

What about for hand soldering? Is it only a temperature of soldering iron (the temperature which is stated on the machine)?
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#8
What about for hand soldering? Is it only a temperature of soldering iron (the temperature which is stated on the machine)?
I have no ideia, because it depends on what you performed during validation. For each validated process, you should have defined parameters. These are the ones to be recorded.
 
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