CARA PEMBUATAN OBAT YANG BAIK

DOKUMENTASI

Apt. Farida Nur Aziza, MGMP.

REFERENCE

• CPOB 2018
• POPP CPOB Jilid 1
• PIC/S GMP GUIDE
• Annex 5 WHO Guidance on Good Data and Record Management
Practices

2
PRINCIPLE
• Essential part of QA system dan GMP requirements compliance
• Documentation form : paper-based, electronic/photographic media
• Objective : establish, control, monitor and record all activities
related to product quality (direct/indirect)
• Document Controls should be implemented  accuracy, integrity,
availability and legibility
• Instruction document  free from errors and available in writing
(recorded/documented on media in human readable form)
 DOKUMEN YANG DIPERLUKAN SESUAI CPOB

1. Site Master File/Dokumen Induk Industri Farmasi

Specification

Manufacturing formulae, processing, Records

3. Record/Report
2. Instruction

packaging, testing instruction

Procedures Certificate of Analysis

Protocols
Reports

Technical/Quality Agreements
GENERATION AND CONTROL OF DOCUMENTATION

Defined and adhered • Appropriate control should be in place for all type of document

Designed, prepared, reviewed, and • The reproduction of working documents  no error

distributed with care

Approved, signed and dated by • Effective date should be defined

appropriate and authorised person

Laid out in order and easy to check • Style, language, mandatory style (SOP, WI, methods)

Regularly reviewed and up-to-date • Systems should ne in place for superseded document

Not in hand-written • If need an entry should have space

GOOD DOCUMENTATION PRACTICES (GDP)

• Handwritten entries  clear, legible, indelible (tidak mudah terhapus)

• Records  should be completed at the time action is taken dan all significant
activities are traceable
• Document entry alteration  signed and dated, permit the reading of original
information, alteration reason is recorded if needed
RETENTION OF DOCUMENTS

Clearly defined for each manufacturing activity and where it is located  secure control for integrity and
validated

Batch documentation  1 yr+expiry date or 5yrs after certification of the batch

Investigational medicinal product  at least 5 yrs after completion/formal discontinuation of the last
clinical trial

Retention period of other documentation  based on business activity

Ex : raw data critical supporting marketing authorisation retained whilst authorisation period  except
superseded by a new data  justification is documented
SPECIFICATION
Starting and packaging
material
• Material description
• Directions for sampling and
testing
• Qualitative and quantitative
requirements with accept.
Limit
• Storage condition and
precaution
• Maximum period of storage
before re-examination
Intermediate and bulk
Finished products
products
• Critical steps  • Name of product and code
purchased/dispatched reference
• Similar to starting • Formula
material/finished products • Pharmaceutical form and
package detail
• Direction for sampling and
testing
• Qualitative and quantitative
requirement & accept. limit
• Storage condition and
precaution
• Shelf life
MANUFACTURING FORMULA AND PROCESSING INSTRUCTION

• Product name with reference code

• Description of pharmaceutical form, strength and batch size
Manufacturing Formula • Starting material to be used  amount
• Expected final yield with accept. Limit and relevant intermediate yield if
applicable

• Processing location and principal equipment

• Methods/reference to method, for preparing critical equipment
• Equipment and work station checks  previous product, document,
material not required, clean equipment
Processing Instructions • Detailed processing instructions
• In-process controls instruction with the limit
• Requirement for bulk storage of the products  container, labelling (if
necessary)
• Special precautions
MANUFACTURING FORMULA AND PROCESSING INSTRUCTION

• Product name , bulk and finished product batch number

• Description of pharmaceutical form, strength and batch size
• Pack size  number, weight/volume in final container
Packaging Instruction • Packaging materials required : quantity, size, type, code
(Approved for each • If appropriate  example of relevant printed pack. materials,
product, pack size, specimens for applying BN and shelf life
type) • Equipment and work station check  line clearance
• Special precaution
• Packaging operation description
• In-process control details  instruction and limits
MANUFACTURING FORMULA AND PROCESSING INSTRUCTION

• Name and batch number

• Dates and times of commencement, significant intermediate stages,
completion of production
• Initials of operator for each process & person who checked the operation
(if appropriate)
• BN and control number  actual weighed starting material quantity
(including any recovered/reprocessed material added)
Batch Processing Record • Processing operation and major equipment used
(kept for each batch) • IPC record and initial of person , the results
• Product yield
• Notes on special problems  details, signed authorisation for any
deviation
• Approval of responsible person for operation
• If using validated process which monitored and controlled 
automatically generated reports  summaries and exception/OOS data
reports
MANUFACTURING FORMULA AND PROCESSING INSTRUCTION

• Name and batch number

• Dates and times of packaging
• Initials of operator for each process & person name who checked the
operation (if appropriate)
• Records of checks  identity and conformity with Packaging Instruction ,
and IPC results
Batch Packaging Record
• Packaging operations details  equipment and packaging line used
(kept for each batch/part • If possible sample of printed pack. materials used  specimen batch
batch processed) coding, expiry date, any overprinting
• Notes on special problems  details, signed authorisation for any
deviation
• Quantities and reference number/identification  all printed packaging
materials and bulk product : Issued, Used, Destroyed/returned to stock,
Obtained product  for RECONCILIATION
• Approval of responsible person for operation
 PROCEDURES AND RECORDS
RECEIPT
• Written procedures and records for receipt of each delivery of starting material (incl. bulk, intermediate/FG,
primary, secondary, printed)
• Include :
1. Name of material on delivery note and container
2. ‘in-house’ name/material code
3. Date of receipt
4. Supplier name and manufacturer name
5. Manufacturer’s batch/ref. number
6. Quantity and number of container receipt
7. Batch number assigned after receipt
8. Any comment
• Written procedure  internal labelling, quarantine and storage of materials

SAMPLING
• Written procedures for sampling  methods, equipment used, amounts to be taken and precautions
 PROCEDURES AND RECORDS
TESTING
• Written procedures for testing materials and products  in each manufacturing stages  methods and
equipment used
• The test should be recorded

OTHER
• Written release and rejection procedures  for materials and products certification for sale of finished
product by authorised person
• All records should be available for authorised person
• A system should be in place for special observations and any changes to critical data
• Records should be maintained for distribution  if necessary for recall
• Clear operating procedures  for major items of manufacturing and test equipment
• Logbooks  major/critical analytical testing, production equipment, areas for product process : use of area,
equipment/method, calibration, maintenance, cleaning/repair  dates and people identity who operated
• Inventory document in quality system should be maintained
• Written policies, procedures, protocols, reports, records for actions taken
PROCEDURES AND RECORDS
Equipment Maintenance,
Validation and Technology
assembly and cleaning,
qualification transfer
calibration sanitation

Personnel Environmental
Pest control Complaints
matters monitoring

Deviation and
non-
Recalls Returns Change control
conformances
investigation

Product quality
Quality audits Supplier audit
review
ALCOA Requirement

Attributable Legible Contemporaneous Original Accurate

• Attributed • Easy to • Made at the • The • Record is

to the read same time as information correct and
correct the action was first provides
author  recorded true record
clearly of events
states who
wrote it
Any Questions?