DISPONIBILIDADE | Agilidade | Parceria
Relacionamento | Experiência | ÉTICA
Comprometimento | PRÓ-ATIVIDADE
Resultados | QUALIDADE | INOVAÇÃO
ANVISA HARMONIZED PROCEDURES SOP 016 – Non-conformities Categorization
and Establishment Classification according GMP Regulatory Risk
DISPONIBILIDADE
Lecturer: Adriane MAIKE Reuwsaat | Agilidade | Paixão
Relacionamento | Experiência | ÉTICA
Comprometimento | PRÓ-ATIVIDADE
Resultados | QUALIDADE | INOVAÇÃO
ANVISA HARMONIZED PROCEDURES SOP 016 – Non-conformities Categorization
and Establishment Classification according GMP Regulatory Risk
• DEFINITIONS of Anvisa SOP 016 – Non-conformities
categorization and Establishment classification according
GMP regulatory risk:
• Establishment on Demand: an establishment which were detected
noncompliance when performing inspection, but with low probability
of harm to health of people.
• Unsatisfactory establishment: an establishment in which were detected
noncompliance when performing inspection with high probability of
injury to health of people.
ORIENS VIGILÂNCIA SANITÁRIA | www.oriensconsultoria.com.br
ANVISA HARMONIZED PROCEDURES SOP 016 – Non-conformities Categorization
and Establishment Classification according GMP Regulatory Risk
• Satisfactory establishment: an establishment which complies
with the requirements of good practices, showing during
inspection absence or a small number of non-conformities, in
accordance with the classification rules set out in this
procedure.
• Noncompliance: Failure to comply with a requirement
specified on the GMP standard, identified in the inspection in
the manufacturing facilities of an establishment and
formalized in the inspection report.
ORIENS VIGILÂNCIA SANITÁRIA | www.oriensconsultoria.com.br
ANVISA HARMONIZED PROCEDURES SOP 016 – Non-conformities Categorization
and Establishment Classification according GMP Regulatory Risk
• Direct Impact Non-conformitie: is a non-conformitie that have
direct influence on the design and control of production of the
products. This nonconformity can directly influence the safety
and efficacy of products manufactured. = 3 points
• Indirect Impact Non-conformitie: is a non-conformitie that has
an impact on the manufacturer's quality system, but does not
have a direct influence on safety requirements and
effectiveness of products manufactured. = 1 point
ORIENS VIGILÂNCIA SANITÁRIA | www.oriensconsultoria.com.br
ANVISA HARMONIZED PROCEDURES SOP 016 – Non-conformities Categorization
and Establishment Classification according GMP Regulatory Risk
APPLICATION OF RULES FOR NON-COMPLIANCE AGGRAVATION. Each non-
compliance shall be increased by 1 point on the following situations:
• NC Recurrence identified in previous inspections, given a history of two
inspections. Noncompliance with different items (eg .: 3.2.1.1 and 3.2.1.2 of
the RDC 16/2013) in the same subclass (ex: 3.2.1 RDC 16/2013) should be
considered as recurrence;
• Absence of documented procedure to compromise the implementation of
any process related to GMP requirements;
• Release of a nonconforming product. The NC has resulted in the release of a
product that does not meet the specified requirements.
ORIENS VIGILÂNCIA SANITÁRIA | www.oriensconsultoria.com.br
ANVISA HARMONIZED PROCEDURES SOP 016 – Non-conformities Categorization
and Establishment Classification according GMP Regulatory Risk
• GMP ESTABLISHMENT CLASSIFICATION:
• SATISFACTORY:
• When are unidentified NC; or
• When are identified up to 5 NC Grade 1.
• ON DEMAND:
• All cases where the establishment is not classified as satisfactory or
unsatisfactory.
• UNSATISFACTORY:
• One or more NC Grade 5; and / or
• More than five NC Grade 4.
ORIENS VIGILÂNCIA SANITÁRIA | www.oriensconsultoria.com.br
ANVISA HARMONIZED PROCEDURES SOP 016 – Non-conformities Categorization
and Establishment Classification according GMP Regulatory Risk
• Note 1: Upon documented risk assessment, taking into consideration the
risk class of the medical device, the inspection team may justify the
framework of the establishment on a distinct classification of the proposal in
this procedure.
• Note 2: With nonconformities that demonstrate the systemic failure of
General Quality System Requirements, the condition of the establishment
should not be classified as satisfactory.
• Note 3: appropriate administrative measures must be taken, including the
possibility of reclassification of the establishment, when failure of adequacy
schedule occurs.
ORIENS VIGILÂNCIA SANITÁRIA | www.oriensconsultoria.com.br
ANVISA HARMONIZED PROCEDURES SOP 016 – Non-conformities Categorization
and Establishment Classification according GMP Regulatory Risk
• ANNEX 1: IMPACT CLASSIFICATION OF ITEMS OF RDC 16/2013
• ANNEX 2: NONCOMPLIANCE CLASSIFICATION EXAMPLES
ORIENS VIGILÂNCIA SANITÁRIA | www.oriensconsultoria.com.br
www.oriensconsultoria.com.br
comercial@oriensconsultoria.com.br
São Paulo | Brasília | Porto Alegre
Contact
Matriz | 55 51 3396-3850
maike@oriensconsultoria.com.br
