Bahan Ajar KSFI

8/10/2019 Bahan Ajar KSFI

1/30

Quality Management Orientation

1. People Integration2. Supplier and Customer Relation

3. Corporate Environment

4. People Capability-ControableProcess

14/10/2014 KSFI-29 1

I. QUALITY MANAGEMENT


2/30

Scope Quality Management

1. Build Quality System for Everyone2. Simple Process not short cut

3. Quality Management Activities :

a. Quality Assuranceb. Quality Planning

c. Quality Control

Quality Management Project Management

14/10/2014 KSFI-29 2


3/30

Quality Characteristic

1. Agenda Manajemen

2. Rencana Bisnis

3. Customer Focuss-Competition-Target

4. Socialized-Training Target to

Everybody

5. Regular View

14/10/2014 KSFI-29 3


4/30


5/30

Kualitas

Langkahlangkah pengendalian kualitas :1. Definisikan dan Set Up Standard

2. Kualifikasi

3. Mengambil Database4. Risk Management

5. Monitoring

6. Review

14/10/2014 KSFI-29 5


6/30

Quality Management Process

1. Quality Management Responsibility

2. Trainer-Improvement-Revolutionary

3. Quality Planning Control

4. Quality Improvement

14/10/2014 KSFI-29 6


7/30

Penyimpangan Mutu

Klasifikasi penyimpangan mutu : Alert

Incident

Significant quality incident

Jika 2 kali alert quality incident

Kategori jumlah produk defect :

1. % variable defect bisa diukur (assay)

2. % attribute defect bisa dilihat (warna)

Perbaikan dan tracking penyimpangan mutu

14/10/2014 KSFI-29 7


8/30

Studi Kasus 1:

Ada sebuah industri farmasi memiliki 5 buah mesintablet dengan kapasitas masing-masing 1.000.000

tablet perhari. Jadi industri farmasi tersebut dalam

sehari memproduksi 5 juta tablet, dalam seminggu

dihasilkan 25 juta tablet (5 x 5 juta), sebulan = 100 juta

tablet, setahun 12 x 100 juta = 1,2 milyar tablet.

Pertanyaannya :

1. Apakah ke-1,2 milyar tablet tersebut SEMUA-nya

dapat dijamin kualitasnya?

2. Berapa persenkah dari 1,2 milyar tablet tadi yangboleh tidak memenuhi syarat yang telah ditetapkan?

14/10/2014 KSFI-29 8


9/30

Jawaban :

1. 0% (NOL PERSEN) alias tidak boleh ada SATU

tablet-pun yang tidak memenuhi syarat. Konsep

ini yang disebut dengan Zero Defect Concept.

2. Konsep ini tidak mungkin berjalan kalau masih

menggunakan konsep Pengawasan Mutu

karena konsep ini hanya mencari kesalahan.

Penjaminan hanya bisa dilaksanakan jika adasistem yang mengatur seluruh komponen

(unsur) dalam industri farmasi tadi agar tujuan

mutu dapat tercapai. Sistem inilah yang sering

disebut dengan Sistem Manajemen Mutu(Qual i ty Management Sys tem).

14/10/2014 KSFI-28 9


10/30

Definisi :

merupakan suatu sistem yang dirancang untuk

melancarkan jalannya suatu proses/pekerjaan dengan

ukuran tertentu yang dapat memenuhi kebutuhan

customer.

Tujuan :

Mempertahankan hasil pekerjaan selalu baik, konsisten

dan mengembangkan rasa memiliki. Pendelegasian :

Harus jelas pada masing-masing departemen dan ada

standar penilaian untuk evaluasi pelaksanaan.

14/10/2014 KSFI-29 10

II. PROCESS OWNERSHIP


11/30

Sasaran :

75% total karyawan memiliki proses ownership atau

individu own many processes.

Manfaat :

Terbentuk sistem yang efektif efisien

SDM dapat mengembangkan diri

Identifikasi permasalahan dengan cepat

Tantangan :

Mau belajar dan mengembangkan ilmu

Mau selalu memikirkan strategi agar sistem dapatberjalan baik

Tidak semua individu mau keluar dari comfort zone

14/10/2014 KSFI-29 11


12/30

Hal-hal yang dapat mensukseskan process ownership :

Fokus pada inti proses

Pribadi yang proaktif

Mau berubah secara bertahap untuk meninggalkan

kebiasaan lama.

Perubahan transisi pribasi mengubah transisi

keseluruhan shg terbentuk organisasi yang efektif.

14/10/2014 KSFI-29 12


13/30

CIRI-CIRI LEADER yang BAIK

1. Envision

Support visi perusahaan dan visi pribadi

2. Enable

Membuat orang bisa mengerjakan tugas dantanggungjawabnya dengan baik

3. Energize

Menyemangati orang agar dapat bersinergi untuk

mencapai tujuan bersama4. Empower

Memberdayakan, mengajak dan mempengaruhi

orang agar ikut sistem yang ada

14/10/2014 KSFI-29 13

III. LEADERSHIP


14/30

Roles & Responsibilities of Leadership

Personal LeadershipDimulai dari diri sendiri dan dapat menjadi contoh

Define requirements and targets

Tetapkan kebutuhan dan target

Standard SettingMembuat standard untuk pribadi dan perusahaan

Understanding of quality principles

Memahami prinsip kualitas dan membangun kualitas

Development of quality culture

Menciptakan kondisi dimana tiap orang paham kualitas danmenjadi budaya sehari-hari

14/10/2014 KSFI-29 14


15/30


Right first time operationMemikirkan cara yang tepat dan menyusun strategi

sebelum mengerjakan sesuatu

Elimination of rework

Menghilangkan rework reduce cost

Establish commitment to quality for everybody

Mengetahui seberapa besar komitmen kita dalam

membangun kualitas

Empower all

Mengajak setiap orang untuk melakukan hal yang baik

demi tercapainya tujuan bersama

14/10/2014 KSFI-29 15


16/30


Definition of site goals Describe quality performance

Deskripsikan penurunan atau kenaikkan produk reject

dengan parameter yang jelas

Consistent with company goalsPerusahaan harus konsisten terhadap kualitas

Quality policy communicated and in place

communication process

Performance and behavior

Terkait dengan pengaturan kedisiplinan

14/10/2014 KSFI-29 16


17/30


18/30

Objectives1. To review general requirements for documents

2. To review specific requirements for each document

3. To consider current issues applicable to your countries

14/10/2014 KSFI-29 18

Why are documents so important?

Communication

Cost

Audit trail

IV. DOCUMENTATION


19/30

General Principles-I

Documentation is an essential part of QA and relates to all

aspects of GMP.

Purpose of documentation

Ensure that there are specifitions for all materials and

methods of manufacture and control

Ensure all personnel know what to do and when to do it

Ensure that authorized persons have all informationneccessary for release

Provide audit trail

14/10/2014 KSFI-29 19

Documents should be

Designed Prepared

Reviewed

Distribution with care

Design documentation


20/30

General Principles-II

Inspectors should look at the Style of the document

Instructions in the imperative

Short sentences

Not long sentences

14/10/2014 KSFI-29 20

General Principles-III Approval of Documentation

Approved, signed and dated by appropriate authorized

personsNo document should be changed without authorization


21/30

General Principles-IV Distribution of documentation

Electronically or photographycally recorded data

14/10/2014 KSFI-29 21

General Principles-V Review

System for regular revision

Completion

During the process


22/30

Typical of Documentation

Labels Specifications and Test Procedures

Master formulae

Batch processing and batch packaging records

Standard operating procedurs

Stock control and distribution records

Water quality manual

Other types (map, flowchart, photograph)

14/10/2014 KSFI-29 22


23/30

Labels

What must be labelled ?

What must be on the label ?

Who has responsibility for labelling ?

14/10/2014 KSFI-29 23

Specifications and Test Procedures

Starting and packaging materials

Intermediates and bulk products

Finished products


24/30

Master Formulae

Manufacturing instructions

Name of product with product reference code

Dosage form, strength and batch size

Full list of materials including quantities, unique reference

code

Expected final yield with acceptable limits

Processing location and principle equipment

Equipment preparation methodology

Stepwise processing instructions

Details of in-process controls with instructions for sampling

and acceptance limits

Storage requirements and special precautions

14/10/2014 KSFI-29 24


25/30

Master Formulae

Packing instructions

Name of the product

Dosage form, strength and method of administration

Pack of size (number, weight or volume of product in finished

pack)

List of all packaging materials (quantities, size and code

number)

Example of printed packaging materials, with location of

batching information

Special precautions, including area cleareance check

Description of the packaging operation

In-process control checks, with sampling instructions and

acceptance criteria

14/10/2014 KSFI-29 25


26/30

Batch Processing Records Name of the product, batch number

Dates and times for major steps in process

Name of person responsible for each stage of production

Name of the operators carrying out each step (check signatures)

Theoretical quantities for materials in the batch

References number and quantity of materials used in the batch

Main processing, steps and key equipment

In-process controls carried out and results obtained

Yield at each stage with comments on deviations

Expected final yield with acceptable limits

Comments on any deviations from process

Area clearance check, instructions to operators

Record of activities

14/10/2014 KSFI-29 26


27/30

Batch Packaging Records

Name of the product, batch number and quantity to bepacked

Batch number, theoretical quantity and actual quantity of

finished product

Reconsiliation calculations, dates and times of operation

Name of person responsible for packaging, initials of

operators carrying out each step

Checks made and results obtained

14/10/2014 KSFI-29 27


28/30

Batch Packaging Records

Details of packaging operation, including equipment and line

used

Returns to store

Specimen of printed packaging materials, with batch coding

Comments on deviations from the process and actions taken

Reconsiliation of packaging materials, including returns and

destruction Area clearance check

Product variables

Record of activities and check signatures

14/10/2014 KSFI-29 28

Standard Operating ProceduresWho is responsible for SOPs ?

Where should SOPs be stored ?


29/30

Standard Operating ProceduresWhich activities require SOPs?

Receipt of all material deliveries

Internal labelling, quarantine and storage of materials Operation, maintenance and cleaning of all instruments and

equipment

Sampling of materials

Batch numbering system

Material testing at all stages of production Batch release or rejection

Maintenance of distribution records

Equipment assembly and validation

Calibration and operation of analytical apparatus

Maintenance, cleaning and sanitation Personnel recruitment, training, clothing and hygiene

Environmental monitoring

14/10/2014 KSFI-29 29


30/30

Stock Control and Distribution RecordsWhat should be recorded ?

Where should records be stored ?

Why are the records important ?

14/10/2014 KSFI-29 30

Water Quality Manual

Full details of design of system, operation and maintenance

Details of testing, requirements

Bahan Ajar KSFI

Documents

Transcript of Bahan Ajar KSFI