1. ISO and GMP
presented by sana Ijaz
10-M-Pceu-2014
UNIVERSITY COLLEGE OF PHARMACY, UNIVERSITY OF THE PUNJAB.

2. ISO (INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION:
 The international organization for standardization is a voluntary
body that develops best practice guidelines for business.
 It is an international standard-setting body composed of
representatives from various national standard organizations.
 163 countries are involved in the creation of ISO, main
secretariat is located in Switzerland.

3. GMP (GOOD MANUFACTURING PRACTICES)
 GMP (Good manufacturing practices) are the practices required
in order to conform to guidelines recommended by agencies that
control authorization and licensing for manufacture and sale of
food, drug products and active pharmaceutical products.
 These guidelines provide minimum requirements that a
pharmaceutical or a food product manufacturer must meet to
assure that the products are of high quality and don't cause any
risk to the consumer.

4. Difference between ISO and GMP:
 ISO and GMP standards both focus on quality assurance, but
there are some differences between the two:
 ISO is a generic, business focused, standard which supports the
effective management of quality to an internationally recognized
level of best practice.
 It is flexible in that it specifies what is to be achieved, but allows
each company freedom to determine, and justify, how these
requirements are achieved.
 In contrast, GMP is an industry-specific standard prescribing
what must be done to ensure product safety and efficacy.

5. Quality Assurance:
 ISO standards help companies learn how to apply
 Quality ,Reliability and Safety criteria.
 They stream line processes and procedures to increase
 Productivity and Minimize inefficiency.
 FDA uses GMP to regulate certain industries to protect
consumers from harm.
 It requires companies to meet specification for manufacturing,
procedures and facilities.

6. Industry Focus:
 As of may 2014,there are 19,500 ISO standards. Some focus on specific
industry needs such as food specific management or manufacturing
engineering.
 Others have a more general business focus such as
 Quality management and Social responsibilities
 FDA’s GMP standards apply only to the
 Drugs,
 medical devices,
 blood and
 certain food cosmetic industries.

7. Voluntary VS Mandatory
 ISO is a voluntary certification obtained by a company when
they determine that the certification is beneficial to their
operations and/or marketing strategies.
 Compliance with GMP is always mandatory, its regulation have
force of law
 If a company fails to meet its obligation, FDA can recall and seize
products
 If the department of justice is involved, companies may have to
pay fines or face criminal prosecution

8. GEOGRAPHICALLY APPROACH:
 ISO comprises 162 standard organizations, each of these
organization has a member, representing the interests of a
specific country so it has internationally approach.
 GMP is also recognized internationally, however this is a
domestic rather than internationally system.

9. Independent certification and its
audited to conformity:
 The ISO certification audit determines quality system’s
uniformity to the ISO standard. Each and every section as well as
the subsections of the standard will be audited assure
conformity.
 The FDA’s GMP audit is based on the FDA’s area of concern, man
power and economics
 FDA may spend two weeks at a company conducting an
inspection, as contrast ISO’ auditors schedule is based on firm
size and no of employees.

10. Quality policy manual:
 For GMP compliance, FDA Is not mandated a company quality
policy manual, only a quality procedure manual.
 However for ISO certification quality policy statement is
requirement.

11. Systematic plan with milestones and
time frames:
 ISO is a process that must be accomplished over an extended
period of time.
 In order to gain staff acceptance for this project, a systematic
plan (with milestones and timeframes) should be prepared, and
everyone should be committed to the plan.
 The plan should be prepared like a Program Evaluation Review
Technique (PERT) chart (working from the final goal–back to the
project initiation) to assure that timeframes are attainable and
realistic.
 There is no such requirement in GMP.

12.  Thank you for your
attention……