Drug Testing Laboratory

Bahawalpur
ISO 17025:2017 Certified

Drug Testing Laboratory Bahawalpur 1

Drug Testing Laboratory Bahawalpur 2
 Building/Functionalization
Project Started 19-02-2010

Completion of Project 30-06-2012

Handing over 14-02-2013

Notification 20-06-2014
Gazette Publication 02.07.2014
“The Punjab weekly Gazette”
DRUG TESTING LABORATORY BAHAWALPUR 4
 Restructuring and Remodeling (Human
Resource, Equipment and Labs)
 Drugs Testing Laboratory Bahawalpur has been
revamped in 2017. Number of seats have been
increased from 8 to 47 including Pharmacists,
Chemist, Biochemist , Microbiologist and
Bacteriologist. Staff has been trained from LGC(
London), TMMDA (Turkey), PFSA(Pakistan), WHO,
USP, Waters (Dubai) and PNAC.
 State of the art LABs equipped with more than 92
Hi-tech latest equipment calibrated from PCSIR.
 CRMs from SIGMA USA and USP
 Calibrated Class A glassware for testing of drugs 5
Drug Testing Laboratory Bahawalpur
 Development Budget

 PC1 (Restructuring & Remodeling of Drugs Testing

Laboratory Bahawalpur) approved with the cost of
164.1M in 30-06-2017.
 Revamped with the expense of 120.742 till June 2020.
A Revised PC1 has been approved recently for the
completion of procurement i.e. 206.442M.
 CurrentRelease of Development Budget(Revenue) at
DDO level 31.00M.
 Expense in F.Y 2020-21= Procurement is under process
Drug Testing Laboratory Bahawalpur 6
 Tenders of FY 2020-2021 from
Development Budget
We are going to purchase new automatic versions of
following high technology instruments.
 HPLC ………………………………………….…………03
 GC-MS…………………………………………………..01
 Automatic Dissolution apparatus
with autosampler…………..…………………………01
 Automatic Disintegration apparatus………….…..01
Drug Testing Laboratory Bahawalpur 6
 Regular Budget 2020-21

 Regular Salary/Non-Salary Budget 2020-21=107.344M

 Total release Budget till date=58.4M

 Total Utilized Budget till date=17.5M

 Expected utilization and procurement = 13 Tenders

having worth of 34 Million are in process
Drug Testing Laboratory Bahawalpur 7
Tenders of FY 2020-2021 from Regular
Budget
 Tender for Lab Chemicals …………………..........…3M
 Tender for Lab Glassware …………………………...2M
 Tender for Reference Standard ………………….2M
 Tender for HPLC Columns …………………………….3M
 Tender for Lab Equipment Accessories …………..3M
 Tender for Stationery ………………………………….1M
 Tender for General Items…………………………….2M
 Tender for I.T Equipment & Accessories…………..1.5M
 Tender for Generator…………………………………..6M
 Tender for Janitorial Services………………………..5M
 Tender for Books & Periodicals………………………1M
 Tender for LGC PT sample……………………………..0.5M 8

 Tender for installation of HVAC……………………4M

 Area of Jurisdiction

DRUG TESTING LABORATORY BAHAWALPUR 8

 Domains of DTL BWP
 Estimated 18.84* Million population is being leveraged with this
project.
 DTL BWP is facilitating two Divisions Bahawalpur & Sahiwal (06
DHQs, 16 THQs and 05 Teaching Hospitals)
 To-date DTL BWP has tested 28,624 medicines out of which 27,379
were pass & 717 were fail.

 Furthermore, MSD Supply, Punjab Employees Social Security

Institutions (PESSI) & Veterinary Medicines along with field samples
from Pharmacies and medical stores are also tested for quality and
safety before human & animal consumption.
* Province wise population Cnesus-2017
21
Drug Testing Laboratory Bahawalpur
 Vacancy Position at DTL Bahawalpur
Sr. # Name of Post Basic Scale No. of Posts Filled Vacant

1 Director BS-20 01 - 01
2 Director Technical BS-19 01 - 01
3 Deputy Drug Controller BS-18 06 03 03
4 Pharmacologist BS-18 01 01 -
5 Sr. Microbiologist BS-18 01 01 -
6 QMS Manager BS-18 01 01 -
7 Analyst / Pharmacist BS-17 16 16 -
8 Analyst / Chemist BS-17 10 08 02
9 Microbiologist BS-17 01 - 01
10 Assistant Bacteriologist BS-17 01 - 01
11 Networking Supervisor BS-17 01 01 -
12 Account / Finance / BS-17 01 01 -
Budget Officers
13 Biochemist BS-17 01 01 -
14 Biomedical Engineer BS-17 01 01 -
15 Data Processing Officer BS-17 01 01 -
DRUG TESTING 16
LABORATORYComputer
BAHAWALPUR Operators BS-15 03 02 01

Total 47 37 10
 Analysis Facility at DTL Bahawalpur
Sr. Laboratory
Main Equipment Laboratory functions
No Name
Weighing balance, Hardness tester, Hygrometer, Physical Analysis of Finish product of different dosage
1 Lab-1 (Physical Lab.)
Friabilator, pH , conductivity tester form.

Disintegration Apparatus, Dissolution Apparatus

Lab-2 (Drug Release
2 Lab.)
manual and auto sampler with UV Dissolution and disintegration of different dosage forms.
spectrophotometer.
Water Bath, Heating Mantle, Sonicator & Chemical identification and analysis of active
conductivity meter, Centrifuge Machine, UV pharmaceutical ingredients in varies dosage forms,
Lab-3 (Wet Chemistry
3 Lab.)
spectrophotometer, Polarimeter, Refractometer, Determination of optical rotation and refractive index of
Soxhlet Apparatus, Electric muffle furnace, drugs.
potentiometer, refrigerator, Fume hood, TLC

Lab-4 (HPLC, High

Identification and analysis of active ingredients in
4 Tech. Lab) HPLC & UPLC Apparatus
various dosage forms.

Autoclave, Laminar Flow cabinet, Incubators, Colony

Lab-5 (Microbiology reader, Electronic Microscopes, Refrigerator, pH
5 Lab.) meter, water bath, fumigator, hot air oven,
Micro assay and sterility of drugs.
hygrometer.

Weighing Balance, Water Bath, Centrifuge Machine,

vertex mixer, Ultrasonic bath, Refrigerator, Samples are prepared before installing over the
6 Lab-6 (preparatory lab)
DRUG TESTING LABORATORY BAHAWALPUR
filtration assembly, pH meter, RO water plant, hot
Hi-Tech Instruments. 10
plate magnetic stirrer, ultrasonic bath, RO water
Plant, hygrometer, Fume hood, Hot oven
 Equipment Status DTL Bahawalpur

Installed Externally Qualification Installation

Equipment Calibrated Pending Pending

92 15 (PCSIR) 00 01

DRUG TESTING LABORATORY BAHAWALPUR 11

 FLOW CHART
WORKING IN DTL
S-2
Physical Comparison of Samples with Form 6 / Forwarding Memo
S-1 Identification mark Brand Name
Receiving of Samples Strength Dosage form S-3
Batch No. Manufacturing Date Data Entry and
By Hand
Expiry Date Manufacturer receiving online
Parcels/Courrier system
Remarks of DI (If any)
Condition of Seal Note: In Case of Any Discrepancy (Wrong Batch No. etc.)Letter to DI/Forwarding Agency
(Sealed/Unsealed) Copy to PQCB

S-6
S-8 S-7 S-5 S-4
Distribution of
Reporting on Preparation of System generated Assigning Bar
samples for
Analytical Form Sample receipt Code
Test/Analysis

S-10
S-9 S-11
Preparation of S-12
Submission of Issuance of Test
analysis result Reports 0n Retention of Sample
DRUG TESTING LABORATORY BAHAWALPUR controlled paper report on Form7 12
 Performance of DTL Bahawalpur

No. of samples No. of samples No. of Samples No. Of

Complete
Received Reported Passed Samples Failed
01-01-2014
To 28624 28097 27379 717
14-02-2019

No. of No. of No. of No. Of

Last Year samples samples Samples Samples PENDENCY
Received Reported Passed Failed
Jan-2020 to
3807 4117 4026 91 243
date

DRUG TESTING LABORATORY BAHAWALPUR 13

 Laboratory of the Government
Chemist(LGC) Audit Report

 Replicate testing and greater use of HPLC assays

evident in Laboratory

 DTL has made significant Improvement towards ISO

17025:2005
Today, DTL BWP has successfully achieved ISO
17025:2005 Certification
Making us Competitive for International Testing &
Reporting 14
Drug Testing Laboratory Bahawalpur
Drug Testing Laboratory Bahawalpur 15
 Achievements
 Successfully completed ISO 17025:2005 accreditation (2018)
 Successfully completed ISO 17025:2017 accreditation with
scope extension (2019)
 Barcode and Drug Testing and Monitoring System (DTMS) online
reporting system ensuring confidentiality of analysis.
 QMS system has been developed and fully implemented.
 Quality analysis reporting according to International Guidelines
and standards such as ICH, WHO and MHRA, comparable with
any International testing laboratory in the world.
 Successfully gone through audits by LGC (UK), PFSA, PQCB and
PNAC with excellent reports
16
Drug Testing Laboratory Bahawalpur
 Milestone Achievements
 Among all DTLs working in Punjab, DRUG TESTING
LABORATORY BAHAWALPUR is leading regarding
ISO SCOPE.
 We have maximum ISO 17025 SCOPE including
 32 products
 Identification and assay
 Weight variation
 pH testing
 Conductivity testing
 Disintegration
Drug Testing Laboratory Bahawalpur
testing 19
 Accredited Scope of DTL BWP
Testing field (e.g.
Types of test/ Reference to standardized method (e.g. ISO
Materials/Products tested environmental testing or
Properties measured 14577-1:2003)/ Internal method reference
mechanical testing)

Paracetamol
Internal Method (DTLB-QMS-MOA-001)/UV-
Active Pharmaceutical Pharmaceutical Testing Quantitative Analysis
absorbance/UV-Visible Spectrophotometer
Ingredient

Paracetamol Tablet Dosage BP, 2020, III-1086 /UV-absorbance/UV-Visible

Pharmaceutical Testing Quantitative Analysis
Form Spectrophotometer

Ibuprofen Active Internal Method (DTLB-QMS-MOA-003)/Liquid

Pharmaceutical Testing Quantitative Analysis
Pharmaceutical Ingredient Chromatography/HPLC

Ibuprofen Tablet Dosage Form Pharmaceutical Testing Quantitative Analysis USP, 2020, I-2285 /Liquid Chromatography/HPLC
Drug Testing Laboratory Bahawalpur 17
 BP, 2020, III-174 /UV-
Atenolol Tablet Pharmaceutical Testing Identification and Assay absorbance/UV-Visible
Spectrophotometer
BP, 2020, III-676 /UV-
Furosemide Injection Pharmaceutical Testing Identification and Assay absorbance/UV-Visible
Spectrophotometer
BP, 2020, III-900 /UV-
Mebeverine Tablet Pharmaceutical Testing Identification and Assay absorbance/UV-Visible
Spectrophotometer
BP, 2020, III-1182 /UV-
Propranolol Tablet Pharmaceutical Testing Identification and Assay absorbance/UV-Visible
Spectrophotometer
BP, 2020, III-776 /UV-
Indometacin Capsule Pharmaceutical Testing Identification and Assay absorbance/UV-Visible
Spectrophotometer
BP, 2020, III-126 /UV-
Allopurinol Tablet Pharmaceutical Testing Identification and Assay absorbance/UV-Visible
Spectrophotometer
BP, 2020, III-819 /UV-
Drug Testing Laboratory Bahawalpur 18
Isotretinoin Capsule Pharmaceutical Testing Identification and Assay absorbance/UV-Visible
Spectrophotometer
 BP, 2020, III-820 /UV-
Isotretinoin Gel Pharmaceutical Testing Identification and Assay absorbance/UV-Visible
Spectrophotometer
BP, 2020, III-1010 /UV-
Naproxen Tablet Pharmaceutical Testing Identification and Assay absorbance/UV-Visible
Spectrophotometer
BP, 2020, III-646 / Liquid
Fluoxetine Capsule Pharmaceutical Testing Identification and Assay
Chromatography/HPLC
USP, 2020, II-3258 / Liquid
Identification and Assay
Chromatography/HPLC
Omeprazole Capsule Pharmaceutical Testing United States Pharmacopoeia
(USP) , 2020, II-3258 / British
Weight Variation
Pharmacopoeia (BP) 2020, III-1050
/Weighing Balance
USP, 2020, I-300 / Liquid
Amoxicillin Capsule Pharmaceutical Testing Identification and Assay
Chromatography/HPLC
USP, 2020, I-793 / Liquid
Carvedilol Tablet Pharmaceutical Testing Identification and Assay
Chromatography/HPLC
USP, 2020, II-3079 / Liquid
Naproxen Tablet Pharmaceutical Testing Identification and Assay
Chromatography/HPLC
US, 2020, II-2675 / Liquid
Loratadine Tablet Pharmaceutical Testing Identification and Assay
Chromatography/HPLC
USP, 2020, I-304 / Liquid
Amoxicillin Tablet Pharmaceutical Testing Identification and Assay
Drug Testing Laboratory Bahawalpur Chromatography/HPLC
19
 United States Pharmacopoeia (USP) , 2020, I-912 /
Cetirizine Oral solution Pharmaceutical Testing pH Testing
British Pharmacopoeia (BP) 2020, III-323 / pH Meter

United States Pharmacopoeia (USP) , 2020, I-882 /

Ceftriaxone Powder for Injection Pharmaceutical Testing pH Testing British Pharmacopoeia (BP), 2020, III-312/ pH
Meter
United States Pharmacopoeia (USP),2020, II-4693 /
Zinc Sulphate Oral solution Pharmaceutical Testing pH Testing
pH Meter
United States Pharmacopoeia (USP) , 2020, II-4653 /
Sterile Water for Injection Pharmaceutical Testing Conductivity Testing British Pharmacopoeia (BP), 2020, II-1290 /
Conductivity Meter

United States Pharmacopoeia (USP) , 2020, I-1015 /

Ciprofloxacin Tablets Pharmaceutical Testing Weight Variation British Pharmacopoeia (BP), 2020, III-364 /Weighing
Balance

United States Pharmacopoeia (USP) , 2020, I-308 /

Co-Amoxiclav Tablets Pharmaceutical Testing Weight Variation British Pharmacopoeia (BP), 2020, III-414 /Weighing
Balance

United States Pharmacopoeia (USP) , 2020, I-394 /

Aspirin Tablet Pharmaceutical Testing Weight Variation British Pharmacopoeia (BP), 2020, III-170 /Weighing
Balance

United States Pharmacopoeia (USP) , 2020, I-1716 /

Esomeprazole Capsule Pharmaceutical Testing Weight Variation
Weighing Balance

United States Pharmacopoeia (USP) , 2020, I-2058 /

Gabapentin Capsule Pharmaceutical Testing Weight Variation British Pharmacopoeia (BP), 2020, III-681/Weighing
Balance
British Pharmacopoeia (BP) , 2020, III-1238 /
Salbutamol Tablets Pharmaceutical Testing Disintegration Testing
Disintegration Apparatus
British Pharmacopoeia (BP) , 2020, III-509 /
Diclofenac sodium Tablets Pharmaceutical Testing Disintegration Testing
Disintegration Apparatus
Drug Testing Laboratory Bahawalpur British Pharmacopoeia (BP)20, 2020, III-947/
Metoclopramide Tablet Pharmaceutical Testing Disintegration Testing
Disintegration Apparatus
WHO Certification

 Drug testing laboratory Bahawalpur has

successfully undergone gap-analysis in 2019 and
laboratory information file submission in 2020.
 Waiting for the pre-audit and date of confirmation
of their on-site visit.

Drug Testing Laboratory Bahawalpur 24

 Goals
 Ensuring the quality medicine, screening out sub-standard
and spurious drugs, ensuring safety of patients.

 WHO Accreditation

 ISO 17025:2017 scope extension

 To attain and sustain the highest standards of testing,

according to pharmacopoeias.
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Drug Testing Laboratory Bahawalpur
 Thank you

23
Drug Testing Laboratory Bahawalpur