2. Sr. No Content Page No
1 Preparation of clinical study
2 Audit and Inspection
3 What to Audit
4 What is difference between
Audit and inspection
5 Who conduct Audit and
6 Audit and inspection studies
7 Self Inspection
8 Reason for Quality Audit
3. PREPARATION OF CLINICAL STUDY
ICH guideline of technical requirements for registration of pharmaceuticals in
ICH guideline includes:
1: Quality 2: Safety
3: Efficacy 4: Multidisciplinary
4. The International Standards Organisation (ISO) has defined a QUALITY AUDIT as;
“A systematic and independent examination to determine whether quality activities and
related results comply with planned arrangements, and whether these arrangements are
implemented effectively and are suitable to achieve objectives”
SELF INSPECTION consists of a periodic detailed examination of conditions and
working procedures by a team from the production site, with the aim of verifying that
good pharmaceutical manufacturing practices are being applied and to propose any
necessary corrective measures to responsible management.
Regulatory agency who conduct the inspections:
1: Food-Drug Administration (FDA)
2: Medicines and healthcare product regulatory agency (MHRA)
3: European medicines Agency (EMA)
5. What to Audit
4: QA& QC
1: Mfg, packing
2:Storage of sample
reagents & solution
6. Difference between Audit and Inspection
Who conduct the Audit & Inspection:
2:The sponsor of the clinical trials
4: IRB & Institutions
1:Inspector employed in
company work for clinical
quality assurance function.
1:Inspector are employed by
government through agency of
the regulatory authority i.e.
2: It ensure that site is
complying with the protocol,
SOP, GCP and regulatory
2: It ensure that trial related
obligations and acceptability of
resultant clinical data is in
support of new drug approval.
Self-inspections should be conducted in order to monitor the implementation and the respect of Good
Manufacturing Practice (GMP) principles and to propose necessary corrective measures.
Personnel matters, premises, Equipment, documentation, production, distribution of the medicinal
products, arrangements for dealing with complaints and recalls, and self-inspection, should be
examined at intervals following a pre-arranged programme in order to verify their conformity with the
principles of Quality Assurance.
Reasons for Quality Auditing
1. Internal Audit — in order to:
Determine the level of compliance
Build confidence in GMP and the QA system
Build interdepartmental trust, understanding, and communication
Determine measures necessary to improve, e.g.
◦ Premises, equipment, environment
◦ Operations, actions, procedures
8. 2. External Audit — in order to:
Establish and monitor capability of supplier or contractor to deliver
goods and services that are fit for purpose (and on time, and in the quantity required)
Build mutual confidence.
Promote understanding and communication between the parties involved.
Monitoring is the act of overseeing the progress of clinical trials and ensuring that it is conducted , recorded
& reported in accordance with the protocol , SOP , GCP and regulatory requirements.
What to monitor:
Adherence to Protocol, GCP, SOP, regulatory Data cleanliness
To ensure consistency
To prevent fraud
To educate study staff on drug handling, protocol procedures and GCPs and safety reporting and ethical
Maintain temporal sequence of event
9. As per WHO:
The science and activities relating to the detection, assessment, understanding and prevention of adverse
effects or any other drug-related problem.
Adverse Drug Reaction: A response to a drug which is noxious and unintended, and which occurs at
doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the
modification of physiological function.
Adverse Event: Any untoward medical occurrence that may present during treatment with a
pharmaceutical product but which does not necessarily have a causal relationship with this
Side Effect :Any unintended effect of a pharmaceutical product occurring at doses normally used in
man which is related to the pharmacological properties of the drug.
AIMS OF PHARMACOVIGILANCE:
Early detection of unknown adverse reactions and interactions
Detection of increases in frequency of (known) adverse reactions
Identification of risk factors and possible mechanisms underlying adverse reaction
Estimation of quantitative aspects of benefit/risk analysis and dissemination of information needed to
improve drug prescribing and regulation.
10. Monitoring of drug safety after introducing into the market through various systems
1.To assess risk benefit ratio
2.To confirm safety and efficacy
3.To detect less common adverse effects
Common procedure for
reporting the ADR given
11. Send your report in a standardized form
for reporting ADRs. The reporting form is self
adhesive postage paid “yellow form”
Dully fill in the ADRs reporting form
(annexed) when encountering an ADR to the
Use a separate form for each patient (refer to
A completed ADRs case report form should
immediately be sealed and mailed. A
completed ADRs case report form should
immediately be sealed and mailed preferably
directly to TFDA within three days.
12. Or through other reporting centers for
onward transmission to the TFDA
Reports can also be submitted online by
going to the TFDA website is given below.
http://www.tfda.or.tz and clicking on
“adverse drug reaction reporting” on the
Reports may be sent by e-mail through the
following e-mail address; email@example.com
13. . ADR reports may be faxed in
cases of perceived urgency
Any follow-up information for an
ADR case that has already been
reported can be sent on another
ADR form, or communicated by
telephone, fax or e-mail.
To enable this information be matched with
the original report it is very important that
follow-up reports are identified and the
following should be indicated in the report;
i. that it is a follow-up information,
ii. the date of the original report and
iii. the patient identities
14. Anecdotal reporting
Intensive event reporting
Cohort studies (prospective)
Case control studies (retrospective)
‘What is not documented is not done!’
‘Document what is done as well as what is not done!’
All information in original records and certified copies of original records of clinical
findings, observations, or other activities in a clinical trial necessary for the
reconstruction and evaluation of the trial. Source data are contained in source
documents (original records or certified copies).
15. ‘What is not documented is not done!’
‘Document what is done as well as what is not done!’
All information in original records and certified copies of original records of clinical findings,
observations, or other activities in a clinical trial necessary for the reconstruction and
evaluation of the trial. Source data are contained in source documents (original records or
16. ‘‘Budgeting in clinical trial”
The estimated amount of money that you need to accomplish the goal of
clinical trial or study.
Study budgets are prepared overall and by each study year with costs
linked to study tasks and patient recruitment.
TOTAL BUDGET INCLUDE:
People who do trial work.
Statistical Analysis and Data Management Support
Travel and meeting.
17. Vendor management:
Vendors performs function on your company behalf of provides
services, goods to your company.
Vendor management is a discipline that enables organizations to
control costs, drive service , excellence and mitigate risks to gain
increased value from their vendors throughout the deal life cycle.
Vendor management include following activities:
Scoping- Policy, Process and Business requirements.
18. Contract- Liability, Terms and conditions, Pricing and Penalties or
Relationship- Transition expectations, common goals People alignment
and cultural fit.
Governance- Roles and responsibility, change management and Risk
Quality audits by Parveen Sultana, Author Stream
Clinical data management by Subhash Amrutham, Author Stream
Introduction to ICH guideline by Piyush Mandhar