ss for the purposes of performing health care in the hospital in question;
must be required to meet the CPOB requirements.
Section 4
The fulfillment of the CPOB and/or CPBBAOB requirements as referred to in Section 2 and Section 3 is evidenced by the certificate.
Section 5
(1) The CPOB certificate is provided for each building unit according to the form of the preparation and manufacture process performed for all stages or part of the stage.
(2) The CPBBAOB certificate is given for each building unit with the type of Active Drug Active Materials created.
(3) The CPOB certificate is published in accordance with the example in Form 1 as attached.
(4) The CPBBAOB certificate is published in accordance with the example in Form 2 as attached.
(5) A list of the CPOB and CPBBAOB Certificate types are listed in the Attachment that are an inseparable part of this Regulation.
(6) A list of CPOB Certificate types as referred to in paragraph (5) may be changed according to the development of science and technology.
Section 6
Based on the study and inspection, the Head of the Agency can publish a CPBBAOB Certificate for the industry which makes the non-efficacy materials used in drug processing with quality standards in accordance with the Pharmacope
BAB III
ORDER TO OBTAIN THE CERTIFICATE
The Kesatu section
Common
Section 7
(1) The CPOB/CPBBAOB certificate is issued under a written request to the Head of the Agency.
(2) The written request as referred to in paragraph (1) is submitted using the Form 3 example as attached.
Section 8
(1) Against the CPOB Certification application it is charged under the provisions of the Government Regulation on Types and Tarif Over Types of State Reception Not Taxes (PNBP) applicable to the Food and Drug Administration (PM).
(2) The charge as referred to in paragraph (1) that has been paid is not retractable.
The Second Part
New Certificate
Section 9
(1) In the order of the new Certification, the applicant delivers the application of the Development Master Plan (RIP) to the Head of the Agency.
(2) Within a period of 14 (fourteen) business days since the acceptance of the RIP conformity evaluation with the requirements of the CPOB.
(3) Based on the evaluation results as referred to in paragraph (2), the Head of the Agency publishes:
a. RIP approval, if declared qualified; or
B. RIP repair request letter, if specified unqualified.
(4) The Head of the Agency (s) authorizes RIP to be granted to the Director.
(5) The applicant report on periodic development progress every 3 (three) months to the Director by using the example Form 4 as attached.
Section 11
(1) After the construction is completed and the qualification is done, the applicant is applying for Certification by using the example Form 5 as attached.
(2) At least 20 (20) business days since the acceptance of the request as referred to in paragraph (1) the Head of the Agency conducts Inspection.
(3) Based on the results of the Inspection as referred to in paragraph (2) the Head of the Agency delivered the evaluation of the fulfilment of the CPOB requirements to the applicant.
The Fourth Part
Certificate issuer
Section 12
(1) Most recently within 10 (ten) business days since it is declared to meet the CPOB requirements based on the evaluation of the inspection results as referred to in Section 11 of the paragraph (2), the Head of the Board publishes:
a. The recommendation of the CPOB requirements as a completeness in the application of the pharmaceutical industry permit; or
B. CPOB certificate.
(2) Special in order of the pharmaceutical industry permit as referred to in paragraph (1) letter a, the CPOB Certificate will be published after the Pharmaceutical Industry obtained the pharmaceutical industry ' s permit.
Section 13
The certificate applies to 5 (five) years as long as it is in production and meets the requirements in accordance with the laws of the laws.
The Fifth Part
Certificate Change
Section 14
(1) Licensee is not able to use any of the following Program licenses:
(2) The term of the certificate as referred to in paragraph (1) follows the prior effective date of the certificate.
The Sixth Part
Reserve
Section 15
(1) The certificate holder is required to apply for a reservation within 6 (six) months prior to the expiration of the certificate.
(2) The application of the reservation is submitted to the Head of the Agency using the example Form 6 as attached.
(3) The reservation is conducted through assessment of the fulfilment of CPOB/CPBBAOB based on routine inspection results, published product history, and/or inspection in order of resercerations when required.
(4) The violation of the obligation of resertification is subject to administrative sanction of a temporary termination of the activities.
BAB IV
MEANINGFUL CHANGE AT THE FACILITY THAT HAS BEEN
GETTING CERTIFICATE
Section 16
(1) Licensee's use of the Program may not be used for any other use of the Program, including any other Program, or any other Program that is subject to the terms of the Program.
(2) The meaningful change as referred to in paragraph (1) includes:
a. production capacity changes due to room changes, equipment changes;
B. changes of the air system and/or water treatment systems;
c. The equipment changes that impact directly on the product sterility;
D. the changes in the biological vendor for the biological product creation process; or
e. There's no
BAB II
Certificate
Section 2
(1) The Pharmaceutical Industry which makes the Drug obliged to meet the requirements on the applicable CPOB Guidelines.
(2) In addition to the provisions as referred to in paragraph (1), the Pharmaceutical Industry which makes the Drug Active Active Materials meet the requirements on the applicable CPBBAOB Guidelines.
Section 3
In addition to the Pharmaceutical Industry as referred to in Article 2:
a. The agency that conducts the process of manufacturing radiofardan's supply and has been given consideration of the agencies authorized in the field of nuclear power supervision; and
B. a hospital pharmacy installation that conducts a drug-making proce
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