Dr. Muslim Suardi, MSi., Apt.

Faculty of Pharmacy, University of Andalas

Good Manufacturing Practice

GMP is a term that is recognized worldwide for the

control & management of manufacturing & QC of
foods, pharmaceutical products, & medical devices
Basic principles
Manufacturing processes are clearly defined & controlled
Manufacturing processes are controlled, & any changes to
the process are evaluated
Instructions & procedures are written in clear
unambiguous language.
Operators are trained to carry out document procedures
Deviations are investigated documented
Basic principles
 Records of manufacture (including distribution) that
enable the complete history of a batch to be traced are
retained in a comprehensible & accessible form.
 The distribution of the drugs minimizes any risk to
their quality.
 A system is available for recalling any batch of drug
from sale or supply.
 Complaints about marketed drugs are examined, the
causes of quality defects are investigated, &
appropriate measures are taken with respect to the
defective drugs & to prevent recurrence.
ASPECTS
Document & Record Control
Sampling Incoming/Receipt of Materials
Warehousing
Laboratory Testing
QA Equipment Calibration Program
Control of QA Equipment
Seaweed Process
Identification & Traceability
Export Procedure
Complaint Handling
Product Recall Procedure
DOCUMENT & RECORD CONTROL

In making sure that all team members

know what is expected of them & in
order to ensure that everyone always has
access to the latest, properly approved
version of a document, the QMS performs
Document Control on all Documents
describing our Certification System.
Document control can be a time- &
paper-consuming process. Even the
simplest of changes often requires an
inordinate amount of time spent in the
preparation, submission, distribution,
implementation of change requests,
document modifications, document
review meetings, document approvals,
document placement.
Documents & Records
Management
GMP document system
Examine the GMP document system, including corporate
standards, master plans, procedures, manufacturing &
test instructions, etc., to determine compliance to
regulatory requirements.
GMP compliance records
Review various records confirm compliance to
requirements.
Record retention
Identify regulatory requirements for GMP compliance in
record retention.
Sampling Incoming/Receipt of
Materials

Incoming materials
Describe & use processes to receive & store incoming
materials, including raw materials, tank farm liquid
chemicals or solvents, components, labels, etc.
 and take appropriate action on deviations, such as
damaged materials, materials from unapproved
suppliers, missing documentation, etc.
Packaging Operations & Controls
 Content protection
 Qualification & maintenance of equipment

 Line clearance operations

 Quality check criteria

 Cut-label procedures

 Hand-applied label procedures

 Production process controls

 Contamination controls

 Tamper-evident packaging
WAREHOUSE
A commercial building for storage of goods.
Are used by manufacturers, importers, exporters,
wholesalers, transport businesses, customs, etc.
Usually large plain buildings in industrial areas of
cities & towns.
Usually have loading docks to load & unload goods
from trucks.
Sometimes load & unload goods directly from
railways, airports, or seaports.
Major warehousing processes
include:
Receiving
Put away
Order preparation / picking
Shipping
Inventory management (cycle counting, addressing...)
WAREHOUSE