HYGIA-INSPIRING TRAINING & EARNING [HITE]
Module: General Training
DOCUMENTATION: LABORATORY IN
A PHARMACY INSTITUTION
Dr. Bharat Mishra, Professor,
Dept. of Pharmacology
& Director, Research & Development
Hygia Group of Institutions
Objectives
● To understand the type of documents required in a typical laboratory.
● To understand the common documents required in a pharmacy laboratory.
● To understand and comply the regulatory requirements for documentation.
● To understand the self explanatory and standard format of documents required in a
pharmacy laboratory.
● To be enabled to develop and maintain the standard lab documents.
Trainees will be enabled after the training:
To create the standard documents required in a pharmacy
laboratory
Type of Documents
1. Personal
Roles and responsibilities of the Lab technicians, general instructions,
technician’s profile, instrument handling manuals, course practical books,
practical manual, PCI requirement list, AKTU requirement list, time tables,
total instrument cost, contact details of the engineers of various companies,
institutional ARC guidelines for the labs and practical conduction etc.
2. Work Assignment:
Syllabus, AKTU and PCI guidelines, Time schedule,
defined process of lab and experiment planning,
availability of material for that planning, policies
and guidelines for conducting the experiments.
3. Log Records
Record of planning of experiments, usage records
for the consumables and non- consumables,
instrument usage, instrument repair schedule and
record, instrument calibration record, purchase
indent record, receiving of goods record.
4. Informative:
Bibliographic styles for the lab, instructions for the student, list of
reference books, websites, tutorials etc. for the students and lab
technicians, manual for the glassware and chemical storage, SOPs
for the machine and processes, guidelines for the chemical storage
methods and rack arrangements. Guidelines for the glassware
cleaning and general maintenance of the instruments, safety
manual for the lab and the laboratory users, guidelines for the
standard treatment of expired chemicals etc. PCI and AKTU
guidelines for the chemical storage and lab infrastructure, exam
guidelines for the external and internal practical.
5. Holding and distribution
Stock register for the chemical and glassware with the date of receiving,
person responsible for receiving, and chemical usage register with the same
particulars. Distribution of lab chemicals record. List of the documents in the
lab, utilization record for the issued material to the lab other than chemicals.
6. Laboratory control
Cleaning schedule, duty chart for the technician and attendance, responsibilities and
hierarchies, confidentiality, exam related authorities and controls, student control etc.
Principal record of the
laboratory:
1.
2.
3.
4.
5.
6.
7.
8.
PLANNING REGISTER
ISSUE REGISTER
STOCK REGISTER
BREAKAGE REGISTER
MAINTENANCE/REPAIR REGISTER
CALIBRATION REGISTER
LOG BOOK REGISTER
LIST OF CHEMICALS AND
GLASSWARES
9. FILE FOR THE XEROX OF THE
ORDER FORM/INDENT FORMS.
10. PROCEDURES FILE/LAB MANUAL
Action Plan for the documentation for the trainees:
Step 1
After receiving a well
discussed training
and the training
document use your
notes to understand
the structure, flow
and sequence of
information in the
document.
Step 2
Have a discussion
with your head of
the institution about
the process of
starting the
documentation.
Step 3
The head of the
institution will
discuss with the
Central ARC head
for the approval and
process clearance.
Step 4
The Central ARC
head will direct to
the institution ARC
head for its
systematic
execution and will
assist for further
clarification.
Step 5
The central ARC head
can intimate the
Director for the changes
in documents and
process.
Step 6
Step 7
This process and the
documents can be
internally audited by the
Central ARC head time
to time for the
assurance.
The IQAC audit will look
into the entire process
and documents in the
schedule audits.
Let's learn the documentation