00 Documentation - Capri, August 2007

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DOCUMENTATION PT. CAPRIFARMINDO LABORATORIES 29 August 2007 By Edi Mulyana

Transcript of 00 Documentation - Capri, August 2007

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DOCUMENTATIONPT. CAPRIFARMINDO LABORATORIES

29 August 2007By Edi Mulyana

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References

• Petunjuk Operasional Penerapan CPOB, Edisi 2001

• PIC/S, GMP PE 009-2, 1 August 2006

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Petunjuk Operasional Penerapan CPOB, Edisi 2001

Dokumentasi adalah sangat esensial dalam mengoperasikan suatu perusahaan farmasi agar dapat memenuhi persyaratan CPOB

Prosedur Tetap, Spesifikasi dan Prosedur Produksi Induk

• Jenis ini adalah dokumen deskriptif berisi instruksi yang menunjukan cara melaksanakan suatu prosedur atau suatu penyelidikan, atau berisi suatu deskripsi dari spesifikasi.

Formulir Pencatatan• Jenis dokumen ini adalah formulir yang digunakan untuk

mencatat data pada saat pelaksanaan tugas, pengujian atau kejadian.

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Petunjuk Operasional Penerapan CPOB, Edisi 2001

Identifikasi • Ini adalah sistem identifikasi atau kode berupa

angka atau abjad ataupun gabungan keduanya yang digunakan untuk menelusuri informasi dan dokumen. Nomor ini mencakup nomor Protap, nomor peralatan, nomor formulir, nomor

penerimaan, nomor bets/lot. Penandaan• Sistem penandaan digunakan untuk

mengidentifikasi status suatu peralatan atau

fasilitas, daerah terbatas atau peringatan.

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PIC/S, GMP PE 009-2, 1 August 2006PRINCIPLE

Good documentation constitutes an essential part of the quality assurance system.

GENERAL

• Specifications describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform.

• Documents should be designed, prepared, reviewed and distributed with care.

• Documents should be approved, signed and dated by appropriate and authorized persons.

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PIC/S, GMP PE 009-2, 1 August 2006GENERAL

• Documents should have unambiguous contents; title, nature and purpose should be clearly stated

• Documents should be regularly reviewed and kept up-to-date.

• Documents should not be hand-written.

• Any alteration made to the entry on a document should be signed and dated

• The records should be made or completed at the time each action is taken

• Data may be recorded by electronic data processing systems, photographic or other reliable means

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CORPORATE PROCEDURE

Unit 1 Unit 2 Unit 3 Capri

PT. SANBE FARMA

CORPORATE PROCEDURE

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DOCUMENTATION STRUCTUREPT. CAPRIFARMINDO LABORATORIES

Capri

III

II

I

Quality Manual

LEVEL I

Standard Operating Procedures

LEVEL II

Records, Form

LEVEL III

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DOCUMENT LEVEL I

• PENGERTIAN

– Panduan bersifat global, yang dibuat oleh Top Manajemen tentang system manajemen yang diterapkan di Organisasi.

– Merupakan dokumen utama yang menjelaskan kebijakan dan sasaran mutu, struktur organisasi, wewenang dan tanggung jawab serta kerangka sistem yang diterapkan.

• NAMA : – QAM (Quality Assurance Manual)– QM (Quality Manual)– PMK (Panduan Manajemen Kualitas)– QMP (Quality Management Procedure)– Dan Lain-lain

• PENANGGUNG JAWAB : Top Management

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• Pengertian

Prosedur yang disusun yang akan dibakukan ke arah implementasi / Penerapan

Menjelaskan cara melakukan pekerjaan secara rinci dan berurutan agar pelaksana kerja dapat berjalan dengan baik.

LEVEL II

• NAMA :

– SOP (Standard Operating Procedure)

DOCUMENT LEVEL I

DOCUMENT LEVEL II

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DOCUMENT LEVEL IV

Pengertian

Formulir yang diisi oleh pelaksana kerja untuk melaporkan hasil kegiatan serta dokumen lain yang dijadikan acuan.

TujuanUntuk menunjukan bukti/hasil tertulis dari kegiatan yang telah dilaksanakan.

LEVEL IIDOCUMENT LEVEL I

DOCUMENT LEVEL III

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DOCUMENT LEVEL IV

Formulir

Setiap Formulir harus memberikan informasi sbb:

Form NumberRevision No. : The number of revision document, newly issued using two digit number “00” and the next revision will be ascending one count.Effective Date : Validity date of a document Page x of y : The pages of document

Format formulir disesuaikan dengan kebutuhan kegiatan

LEVEL IIDOCUMENT LEVEL I

DOCUMENT LEVEL III

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Preparation of Standard Operating Procedure (SOP)

DCC-DC/SOP/CP/002

DAFTAR ISI / TABLE OF CONTENTS

TUJUAN / PURPOSE

RUANG LINGKUP / SCOPE

DEFINISI / DEFINITION

PUSTAKA / REFERENCE (If Needed)

TANGGUNG JAWAB / RESPONSIBILITIES

PROSEDUR / PROCEDURES

FREKUENSI PENINJAUAN ULANG / REVIEW FREQUENCY

LAMPIRAN / APPENDIX (If Needed)

SEJARAH REVISI / REVISION HISTORY

Setiap dokumen level II minimum mempunyai daftar isi sebagai berikut :

TABLE OF CONTENTS

PURPOSE

SCOPE

DEFINITION

REFERENCE (If Needed)

RESPONSIBILITIES

PROCEDURES

REVIEW FREQUENCY

APPENDIX (If Needed)

REVISION HISTORY

BAHASA INDONESIA ENGLISH LANGUAGE

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Preparation of Standard Operating Procedure (SOP)

DCC-DC/SOP/CP/002

HEADER CONTENT

TYPE OF DOCUMENTPage x of y

PT. CAPRIFARMINDO LABORATORIES Revision No.: xx

Subject : Document No. :Next Review Date:

Location/Department :

Effective Date Prepared by, Reviewed by, Reviewed by, Approved by,

ORIGINAL Confidential

• Header Page 1 / Hanya untuk Halaman pertama

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Preparation of Standard Operating Procedure (SOP)

DCC-DC/SOP/CP/002

HEADER CONTENT

• Header Page 2 onward /Untuk Halaman kedua dan seterusnya

Document No. : Rev. : xx Page x of y

Prepared, Reviewed, Reviewed, Approved,

ORIGINAL Confidential

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• Signature

Signature for header first page must use complete signature and date

Signature for header second page onward must use initial without date

LEVEL IIPreparation of Standard Operating Procedure (SOP)

DCC-DC/SOP/CP/002

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FOOTER CONTENT

The document should have footer on every page containing:

• The Filename of document in the server (LAN)• Release• Capri• Code of Department and Section or Based of Process Code• Type of Document• Document number• Horizontal dash ( - )• Sort title of the subject• Horizontal dash ( - )• Revision number

Example :

\\Cimareme\Release\Capri\PRO\NS\SOP\PRO-NS.SOP.CP.010 - Handling and Control - R00.doc

LEVEL IIPreparation of Standard Operating Procedure (SOP)

DCC-DC/SOP/CP/002

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FORMATTING

• Margin

Top : Page 1 3.19” Page 2 onward 1.25”

Bottom : 0.7”Left : 1” Right : 0.7”

• Paper Size

Size : A4 ( 210 x 297 mm )Width : 8.27”Height : 11.69”

Preparation of Standard Operating Procedure (SOP)

DCC-DC/SOP/CP/002

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FORMATTING

• Font

• Font of all documents shall use Times New Roman • except logo of CAPRI use size: Height 0.38” Width 1.17”

• Paragraph

• Line spacing for title of table of content shall use 1.5 lines type • Line spacing for all sentences shall use single type

• Alignment shall use justify type

Preparation of Standard Operating Procedure (SOP)

DCC-DC/SOP/CP/002

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FORMATTING

• Language

Standard operating procedure document shall use English or Indonesian languages.

• End of Document

Last page of the document shall be a revision history containing :

• Revision Number• Date• Description• Originator Example : Attached I/E

Preparation of Standard Operating Procedure (SOP)

DCC-DC/SOP/CP/002

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DOCUMENT LEVEL IV

Formulir

Setiap Formulir harus memberikan informasi sbb:

Form NumberRevision No. : The number of revision document, newly issued using two digit number “00” and the next revision will be ascending one count.Effective Date : Validity date of a document Page x of y : The pages of document

Format formulir disesuaikan dengan kebutuhan kegiatan

Preparation of FORM

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FORM

LEVEL III

No.RevisionEffective DatePage

: : 00:: x of y

Approval

DOCUMENT LEVEL IVPreparation of FORM

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Format

XXX-YY / ZZZ / QQ / SSS

a b c d

Sequence Number

Location in specific/Plant

Document Type

Process/Department- Section

LEVEL IIDocument Numbering System

DCC-DC/SOP/CP/003

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Example

XXX-YY / ZZZ / QQ / SSS

a b c d

LEVEL II

Production - Liquid PRO-LI/SOP/OS/002

Document Numbering System

DCC-DC/SOP/CP/003

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Quality Manual

LEVEL II

Document Code in Capital Letter/CP/2-digits revision number

Example : QM/CP/00 QM is code of Quality manual CP is code of Caprifarmindo 00 indicates the first issuance and ascending for the next revision

Document Numbering System

DCC-DC/SOP/CP/003

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Record

LEVEL III

The evidence of working implementation shown in record it such as forms, models, and any other type as the carried out work.

Classes (Record Storage) Class of Process Records : Test and Inspection Report

Batch Record Calibration Data Receiving Inspection and Test Records In Process Operational Data

Class of Management Records : Internal Audit Reports Supplier Audit Reports Cost of Quality Analysis Reports Non Conformance History Reports Validation and Calibration Reports

Record Control

DCC-RC/SOP/CP/001

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LEVEL II

Document originator shall provide softcopy of document approved to Document Controller to be stored in this server : \\Cimareme\DCC\Capri\SoftcopyThis server can only be accessed by Document Controller

Document Controller shall change the document format from received softcopy into Acrobat Reader format and store the PDF document in this server :\\Cimareme\Release\Capri\Document All personnel who have access to this server can only read all documents.

General form shall be stored in this server :\\Cimareme\Release\Capri\FormThis server can be accessed by all personnel

Softcopy of obsolete Controlled Document shall be stored in this server : \\Cimareme\DCC\Capri\ObsoleteThis server can only be accessed by Document Controller

Backup of Electronically Stored Document

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LEVEL II

Controlled Document :

Documents which are distributed to determined department and if any change or revision on the documents, Document Controller must submit the current revision and make sure that the previous documents are withdrawn.

Uncontrolled Document :

Documents may be issued to persons who are not part of the distribution Sheet of Document. These are to be used for training, reference and information purposes only and if any change or revision on the documents, Document Controller is allowed neither to submit the current revision nor to withdraw the previous documents.

LEVEL IIIDocument Control

DCC-DC/SOP/CP/001

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LEVEL II

Prepared :

Functionary of PT Caprifarmindo Laboratories who has authority and responsibility to prepare a document required by respective department

Reviewed :

Functionary of PT Caprifarmindo Laboratories who has authority and responsibility to review documents before released

Approved :

Functionary of PT Caprifarmindo Laboratories who has authority and responsibility to review and approve documents before released

Effective Date :

Validity date of a document is given after Originator/Author of the document performs training to related party. The date of training can be the same date as the approval date, which resulted the date of effective date will be the same as the approved date.

See Matrix of Authority and Responsibility

LEVEL IILEVEL IIIDocument Control

DCC-DC/SOP/CP/001

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LEVEL II

Identify Required documents

Department Manager

Arrange new/revised required documents

Originator/Author

DCC-DC/SOP/CP/002DCC-DC/SOP/CP/003

Circulated ?

Submit the document for approval refer to

Matrix of Authority and Responsibility

Document Controller

Appendix 8.1

Reviewing and Evaluating the

document prior to approved

Related Functionary

Appendix 8.1

Approved ? Document Issued

Document Controller

Record in the form of Master List of

Document

Document Controller

DCC-DC/FOR/CP/001

Discussed result of circulate for comments

or alterations

Originator/Author

Circulate for review/comment the document

to related parties.

Document Controller

DCC-DC/FOR/CP/008

Return to Document Controller for repaired by Originator/Author

Document Controller

Yes

01

No

oN

Yes

New or revised document ?

New

Submit proposed document change

request form

Originator/Author

COQA/FOR/001New

Revised

Duplication original document as many as

number of recipient

Document Controller

DCC-DC/FOR/CP/002

Distributed copy of approved document to

recipients

Document Controller

DCC-DC/FOR/CP/002

Original or Copy document ?

Copy

Update Master List of Document

Document Controller

DCC-DC/FOR/CP/001

Establish recipients of controlled document

Originator/Author

DCC-DC/FOR/CP/002

01

Controlled Document ?

Store original document at Document Control

Center

Document Controller

DCC-DC/FOR/CP/001

Stamp “Uncontrolled Copy”

Document Controller

DCC-DC/FOR/CP/004

Stamp “Controlled Copy”

Document Controller

DCC-DC/FOR/CP/002

Original

No

NoIs old document

withdrawn ?

Return to Document Control Center for

destroyed

Document Controller

Stamp “Obsolete”

Document Controller

Do disposition for obsolete controlled

document.

Document Controller

DCC-DC/FOR/CP/001

Yes

Yes

Document Control DCC-DC/SOP/CP/001

Document Release Flow

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LEVEL II

Request of Document

Distribute to Outer Company

Destruction of Document

LEVEL IILEVEL IILEVEL IIIDocument Control

DCC-DC/SOP/CP/001

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LEVEL II

Document Storage

1) Quality Manual

2) Standard Operating Procedure

3) Record

4) Form

5) External Document

List

Document Control

DCC-DC/SOP/CP/001

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LEVEL II

Document Storage

Confidential Original Document

(e.g. Master Batch Record / Packaging Record)

shall be stored by Department Manager who issues the document. Department Manager only gives information of document number, title and revision to Document Control Center for registration purpose and

put on the Master List of Document.

Document Control

DCC-DC/SOP/CP/001

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End Presentation

• Thank You