00 documentation - capri, august 2007
TRANSCRIPT
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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