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Transcript of 00 Documentation - Capri, August 2007

DOCUMENTATIONPT. CAPRIFARMINDO LABORATORIES 29 August 2007 By Edi Mulyana

References Petunjuk Operasional Penerapan CPOB, Edisi 2001 PIC/S, GMP PE 009-2, 1 August 2006

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.

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.

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

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

CORPORATE PROCEDURE

PT. SANBE FARMA

CORPORATE PROCEDURE

Unit 1

Unit 2

Unit 3

Capri

DOCUMENTATION STRUCTUREPT. CAPRIFARMINDO LABORATORIES

Capri

LEVEL IQuality Manual

ILEVEL II

II

Standard Operating Procedures

LEVEL III

III

Records, Form

DOCUMENT LEVEL I NAMA : QAM (Quality Assurance Manual) QM (Quality Manual) PMK (Panduan Manajemen Kualitas) QMP (Quality Management Procedure) Dan Lain-lain PENANGGUNG JAWAB : Top Management 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.

LEVEL II DOCUMENT LEVEL II

DOCUMENT LEVEL I NAMA :

SOP (Standard Operating Procedure) 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 DOCUMENT LEVEL III DOCUMENT LEVEL IV

DOCUMENT LEVEL IPengertianFormulir 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 II DOCUMENT LEVEL III DOCUMENT LEVEL IV

DOCUMENT LEVEL IFormulirSetiap Formulir harus memberikan informasi sbb:Form Number Revision 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 Standard Operating Procedure (SOP)DCC-DC/SOP/CP/002Setiap dokumen level II minimum mempunyai daftar isi sebagai berikut :DAFTAR ISI / TABLE OF CONTENTS TUJUAN / PURPOSE RUANG LINGKUP / SCOPE DEFINISI / DEFINITION PUSTAKA / REFERENCE (If Needed) TANGGUNG JAWAB / RESPONSIBILITIES PROSEDUR / PROCEDURES FREKUENSI PENINJAUAN ULANG /

TABLE OF CONTENTS PURPOSE SCOPE DEFINITION REFERENCE (If Needed) RESPONSIBILITIES PROCEDURES REVIEW FREQUENCY APPENDIX (If Needed) REVISION HISTORY

REVIEW FREQUENCY

LAMPIRAN / APPENDIX (If Needed) SEJARAH REVISI / REVISION HISTORY

BAHASA INDONESIA

ENGLISH LANGUAGE

Preparation of Standard Operating Procedure (SOP)DCC-DC/SOP/CP/002

HEADER CONTENT Header Page 1 /ORIGINAL ConfidentialPage x of y

Hanya untuk Halaman pertama

TYPE OF DOCUMENTPT. CAPRIFARMINDO LABORATORIES

Revision No.: xx :

Subject

Next Review Date:Document No. :

Location/Department : Effective Date Prepared by, Reviewed by, Reviewed by, Approved by,

Preparation of Standard Operating Procedure (SOP)DCC-DC/SOP/CP/002

HEADER CONTENT Header Page 2 onward /Untuk Halaman kedua dan seterusnya

ORIGINAL ConfidentialDocument No. : Prepared, Reviewed, Rev. : xx Reviewed, Page x of y Approved,

LEVEL II Preparation of Standard Operating Procedure (SOP)DCC-DC/SOP/CP/002

SignatureSignature for header first page must use complete signature and date Signature for header second page onward must use initial without date

LEVEL II Preparation of Standard Operating Procedure (SOP)DCC-DC/SOP/CP/002

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

Preparation of Standard Operating Procedure (SOP)

DCC-DC/SOP/CP/002

FORMATTING Top

Margin

: Page 1 3.19 Page 2 onward 1.25 Bottom : 0.7 Left : 1 Right : 0.7

Paper Size: A4 ( 210 x 297 mm ) : 8.27 : 11.69

Size Width Height

Preparation of Standard Operating Procedure (SOP)

DCC-DC/SOP/CP/002

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

FORMATTING LanguageStandard operating procedure document shall use English or Indonesian languages.

End of DocumentLast page of the document shall be a revision history containing : Revision Number Date Description Originator

Example : Attached I/E

Preparation of FORM

DOCUMENT LEVEL IVFormulirSetiap Formulir harus memberikan informasi sbb:Form Number Revision 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 LEVEL III

DOCUMENT LEVEL IVFORMNo. Revision Effective Date Page : : 00 : : x of y

Approval

Document Numbering LEVEL System II

DCC-DC/SOP/CP/003

FormatXXX-YY / ZZZ / QQ / SSSa b c d

Sequence Number Location in specific/Plant

Document TypeProcess/Department- Section

Document Numbering LEVEL System II

DCC-DC/SOP/CP/003

ExampleXXX-YY / ZZZ / QQ / SSSa b c d

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

Document Numbering LEVEL System II

DCC-DC/SOP/CP/003

Quality ManualDocument 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

Record Control

LEVEL III

DCC-RC/SOP/CP/001

RecordThe 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

Backup of Electronically Stored Document

LEVEL II

Document originator shall provide softcopy of document approved to Document Controller to be stored in this server : \\Cimareme\DCC\Capri\Softcopy This 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\Form This server can be accessed by all personnel Softcopy of obsolete Controlled Document shall be stored in this server : \\Cimareme\DCC\Capri\Obsolete This server can only be accessed by Document Controller

Document Control

LEVEL III II

DCC-DC/SOP/CP/001

Controlled Document

:

Documents which are distributed to determined department and if any change or revision on the do