Panexcell Clinical Lab Private Limited
Panexcell Clinical Lab Private Limited
CRO offering BA/BE and allied clinical services to
pharmaceutical, biotechnology and medical device
companies.
Panexcell Clinical Lab Private Limited
Our Vision
“Our vision is to become a world class CRO by
ensuring conformance to highest ethical and
quality standards.”
Our Mission
“To be one of the most trusted partners to our
clients in the pharmaceutical industry through
compliance to all regulatory requirements to
develop products to improve the quality of
human life.”
“To build long-lasting relationships with our
clients by providing quality data in a timely and
cost-effective manner through our team of
experienced and dedicated professionals.”
Key Personnel
Name
Designation Qualification Experience
Area of specialization
Medical
Advisor
Ph.D.
30
Biochemistry
Mr. Nelson Varghese
Head-Technical
Operations
M.Sc. & MBA
20
Master of Science in Organic
Chemistry
Dr. Ajaykumar Malle
Principal
Investigator
M.B.B.S.
12
BA/BE studies , Phase III
trails, Medical writing.
Dr. Bharat Raut
Head –
Bioanalytical
Ph.D.
24
Chemistry
Head – Quality
Assurance
Ph.D.
10
Analytical Chemistry
AM – Clinical
Trials
B. Sc. & PG Dip
Clinical
Research
5
Clinical Trials
Dr. Satish Bhatia
Dr. Suvarna Bhoir
Mr. Nishant Lal
Organogram
Infrastructure
Premises:
• In 2006 at Rabale (Navi Mumbai –
India)
• Area – 20000 sq. ft.
Clinical Facility:
• 58 beds
• 2 beds (Emergency Care Unit)
Bio-Analytical Facility:
• 7 LCMS/MS (2 API 5500, API 4000,
API3200, 2 API 3000, Thermo
Discovery)
Employee Strength:
• Above 110 personnel
Clinical Units
• Spread over 8000 sq. ft. space.
• 2 air-conditioned wards with a total of 58
beds.
• Access control for male and female wards.
• Database of more than 6000 healthy
volunteers including 750 female
volunteers.
• Fully equipped ECU facility.
• Remote monitoring with CCTV.
• Phlebotomy room with separate matrix
processing room.
• Pharmacy with controlled access.
• Dining area with in-house kitchen.
• Screening room.
• Counseling room with audio-video
recording facility.
• Ambulatory room.
• Examination & Monitoring rooms.
• Recreation hall.
Bio-analytical Unit
• Spread over 4000 sq. ft. space
• Wet lab with multiple processing
counters
• Dark room for light-sensitive
molecules
• LCMS/MS Lab with instrument.
• Equipment's and software's, 21
CFR part 11 compliant
• Micro-balance room
• Chemical storage room
• Remote monitoring with CCTV
• Data management.
Bio-analytical instruments
• LCMS/MS:
• API 5500 (2 no's)
• API 4000
• API 3200
• API 3000 (2 no's)
• Discovery (Thermo Finnigan)
• UV spectro/micro-plate reader
• Fume hood (2 no's)
• Automated evaporator (2 no's)
• Analytical balance
• Micro balance
• Refrigerated centrifuge (3 no's)
• Deep freezers (9 no's)
• Eurotherm data logger
• Water purification system
Utilities
• Fully air-conditioned facility
• Multiple Power back up generator
with100kva and 20kva capacities
• UPS for all instrumentation and
computers
• Scroll pumps and nitrogen
generators
Sub-contracts (Outsourcing)
Sr. No.
Name of Sub Contractors
Activity outsourced
1
2
3
4
5
6
7
8
9
Getwell Diagnostics Lab
Metropolis Lab
Dr. Jairaj Diagnostic Centre
Alert EC
Ethos
Criticare Hospital
Mayuresh Associate
Navi Mumbai Bio-waste Agency
CSBL
Pathology test
Pathology test
Pathology test
Ethic Committee
Ethic Committee
ECU, Radiology services
Calibration
Bio-waste disposal
Archival
Services
Provides a Broad Range of Services Under
“One Roof”
Bio-Availability / Bio-Equivalence Studies
Clinical Trials Services
Pharmacokinetic Studies with NDDS & NCEs
Statistical Analysis
Data Management
Medical Writing
Special Population Studies
Pharmacokinetic Studies
Services
• Single dose and multiple dose kinetics
• Oral / Parenteral / Nasal / Local Formulations
• Evaluation of Immediate / Controlled / Delayed release
dosage forms under Fasting / Food effect
• Special population studies (Postmenopausal females)
Therapeutic areas
• Analgesics
• Hormones
• Anti hypertensive
• Hypoglycemic agents
• Anti Malarial
• Immunosuppressant
• Antibiotic/ Antimicrobial
• Lipid lowering agents
• Anticonvulsant
• Muscle relaxants
• Antidepressant
• NSAIDs
• Antiretroviral
• Oral contraceptive
• Cardiovascular
• Psychotropic agents
Quality Assurance
• Quality Assurance at Panexcell is an independent function and
ensures ethical conduct of clinical studies as per GCP, GLP &
other applicable regulatory requirements.
• Approval, review, distribution and implementation of SOPs
• Responsible for in-process and retrospective audits
• Training the staff on SOPs
• Interfacing for sponsor and regulatory audits
• Archival
Training Schedule
Month
JAN
FEB
General
SOPs /
Statistical
Training
General
SOPs
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
NOV
DEC
General
EOPs
DepartmentalDepartmentalDepartmental
SOPs
SOPs
SOPs
DepartmentalDepartmentalDepartmental
SOPs
SOPs
SOPs
GLP / GCP /
Manuals
Regulatory
Guidelines
Safety
Training
Archival
An isolated archival section at PCLPL
facilitates reconstruction of study as per
regulatory requirement.
In-house facility:
Panexcell Clinical Lab Private Limited
R-374, TTC MIDC, Rabale, Navi Mumbai
Third Party archival facility:
For hard copy:
Capital Records Centre Pvt. Ltd.
Dapode village, Taluka Bhiwandi, Mumbai.
For soft copy:
HDFC Bank Limited
Turbhe, Navi Mumbai.
&
Prism Consultancy
Ahmedabad.
General SOPs
Sr. No.
List of SOPs
SOP Title
SOP No.
1
2
3
4
5
6
7
8
9
Preparation, Review, Approval, Authorization, Distribution and Revision of Standard Operating Procedure
Training of Personnel
Document Control
Change Control
Documentation, Data Handling and Record Keeping
Safety at PCLPL
Archival and Retrieval
Procedure for Assigning Identification Codes to Clinical and Bioanalytical Project Documents
General Housekeeping and Sanitary Procedure
PCLPL-GN-SOP-01-00
PCLPL-GN-SOP-02-00
PCLPL-GN-SOP-03-00
PCLPL-GN-SOP-04-00
PCLPL-GN-SOP-05-00
PCLPL-GN-SOP-07-00
PCLPL-GN-SOP-08-00
PCLPL-GN-SOP-09-00
PCLPL-GN-SOP-10-00
10
11
12
13
14
15
16
Access Control
Electricity Supply - Failure Handling
Equipment Qualification
Bio-Waste Management
Role and Responsibilities of Personnel at PCLPL
Preparation of Calibration Plan
Recording of Temperature and Humidity
PCLPL-GN-SOP-11-00
PCLPL-GN-SOP-12-00
PCLPL-GN-SOP-14-00
PCLPL-GN-SOP-15-00
PCLPL-GN-SOP-16-00
PCLPL-GN-SOP-17-00
PCLPL-GN-SOP-18-00
17
18
19
Defining Units, Number of Digits and Rounding off Procedure for Reporting of Project Data
Management Review System
Data Transfer and Acceptance for Biostatistics
PCLPL-GN-SOP-19-00
PCLPL-GN-SOP-21-00
PCLPL-GN-SOP-22-00
20
21
Quality Control
Preventive Maintenance of Instruments
PCLPL-GN-SOP-25-00
PCLPL-GN-SOP-26-00
22
23
24
Preparation and Updation of Project Plan
Procedure for Disaster Recovery
Procedure for Assigning Identification Number to Instruments
PCLPL-GN-SOP-27-00
PCLPL-GN-SOP-28-00
PCLPL-GN-SOP-29-00
General EOPs
Sr. No.
List of SOPs
SOP Title
SOP No.
1
Operation and Maintenance of Emergency Shower and Eye Washer
PCLPL-GN-EOP-01-00
2
Operation and Calibration and Maintenance of Thermohygrometer
PCLPL-GN-EOP-02-00
3
Operation, Calibration and Maintenance of Data Logger
PCLPL-GN-EOP-03-00
4
Operation, Calibration and Maintenance of Clocks
PCLPL-GN-EOP-04-00
5
Operation, Calibration and Maintenance of Gas Leak Detector
PCLPL-GN-EOP-05-00
6
Operation and Calibration of Data Logger ebro EBI 300
PCLPL-GN-EOP-06-00
7
Operation and Calibration of Data Logger ebro EBI 20
PCLPL-GN-EOP-07-00
8
Operation of Data Logger RTD-CCMS
Procedure for Operation, Calibration, Maintenance and Record
Keeping of Data Logger
PCLPL-GN-EOP-08-00
9
PCLPL-GN-EOP-09-00
List of SOPs
Bio-analytical SOP’s
Sr. No.
1
SOP Title
Procurement, Storage, Usage, Maintenance and Disposal of Reference
Standards/ Working Standard
SOP No.
PCLPL-BA-SOP-01-00
2
Handling and Maintenance of Chemicals, Reagents and Solvents
PCLPL-BA-SOP-02-00
3
Procurement, Identification and Storage of Biological Matrix
PCLPL-BA-SOP-03-00
4
Procurement, Storage and Maintenance of Analytical Columns
PCLPL-BA-SOP-04-01
5
Labeling Procedure in Bioanalytical Department
PCLPL-BA-SOP-05-00
6
Cleaning of Laboratory Glass Wares
PCLPL-BA-SOP-06-00
7
Collection, Storage and Disposal of Laboratory Chemicals and Reagents
PCLPL-BA-SOP-07-00
8
Acceptance of Chromatographic Data and Verification of Chromatograms
PCLPL-BA-SOP-08-00
9
Handling of Rejected Chromatographic Data
PCLPL-BA-SOP-09-00
10
Guidance on Bioanalytical Method Development
PCLPL-BA-SOP-10-00
11
Recording of Raw Data in Bioanalytical Department
PCLPL-BA-SOP-11-00
12
Preparation of Stock Solution, Dilutions, CCs and QCs
PCLPL-BA-SOP-12-00
13
System Suitability
PCLPL-BA-SOP-13-00
14
Preparation and Approval of Method Validation Protocol
PCLPL-BA-SOP-14-00
List of SOPs
Bio-analytical SOP’s
Sr. No.
SOP Title
SOP No.
15
Validation of Bioanalytical Methods
PCLPL-BA-SOP-15-00
16
Preparation and Approval of Method Validation Report
PCLPL-BA-SOP-16-00
17
Receipt, Storage, Issuance and Disposal of Samples
PCLPL-BA-SOP-17-00
18
Subject Sample Analysis and Batch Acceptance Criteria
PCLPL-BA-SOP-18-00
19
Repeat Analysis
PCLPL-BA-SOP-19-00
20
Preparation and Approval of Bioanalytical Subject Analysis Report
PCLPL-BA-SOP-20-00
21
Compilation of Raw Data in Bioanalytical Department
PCLPL-BA-SOP-21-00
22
Incurred Sample Re-Analysis
PCLPL-BA-SOP-22-00
23
PCLPL-BA-SOP-23-00
24
System Suitability for Ligand Bind Assays
Quantitative Ligand Binding Assays : Preparation of Calibration Curve
Standards, Quality Control Samples, Assay Specifications and Acceptance
Criteria
25
Recording of Raw Data for Ligand Bind Assay
PCLPL-BA-SOP-25-00
26
Validation of Bioanalytical Methods by Using Ligand Binding Assays
PCLPL-BA-SOP-26-00
27
Role and Responsibilities of Custodian
PCLPL-BA-SOP-27-00
28
Preparation and Approval of Method SOP
PCLPL-BA-SOP-28-00
PCLPL-BA-SOP-24-00
List of SOPs
Bio-analytical EOP’s
Sr. No.
SOP Title
SOP No.
1
Operation, Calibration and Maintenance of Pipettes
PCLPL-BA-EOP-01-00
2
Operation, Calibration and Maintenance of Refrigerated Centrifuge
PCLPL-BA-EOP-02-00
3
Operation, Calibration and Maintenance of Centrifuge
PCLPL-BA-EOP-03-00
4
Operation and Maintenance of Sonicator
PCLPL-BA-EOP-04-00
5
Operation, Calibration and Maintenance of Refrigerators
PCLPL-BA-EOP-06-00
6
PCLPL-BA-EOP-07-00
8
Operation, Calibration and Maintenance of Deep Freezers (SANYO)
Operation, Calibration and Maintenance of Deep Freezers (NEW
BRUNSWICK)
Operation, Calibration and Maintenance of Sartorius Analytical Balance
(Model. CP224S)
9
Operation, Calibration and Maintenance of Turbo Evaporator
PCLPL-BA-EOP-10-00
10
Operation, Calibration and Maintenance of Mass Spectrometer (Thermo)
Operation, Calibration and Maintenance of Mass Spectrometer (Applied
Biosystems)
PCLPL-BA-EOP-11-00
7
11
12
PCLPL-BA-EOP-08-00
PCLPL-BA-EOP-09-01
PCLPL-BA-EOP-12-00
PCLPL-BA-EOP-13-00
13
Operation, Calibration and Maintenance of Hot Air Oven
Operation, Calibration and Maintenance of Solid Phase Extraction (SPE)
Processor
14
Operation, Calibration and Maintenance of pH Meter
PCLPL-BA-EOP-15-00
PCLPL-BA-EOP-14-00
List of SOPs
Bio-analytical EOP’s
Sr. No.
SOP Title
SOP No.
15
Operation, Calibration and Maintenance of Micro Balance
PCLPL-BA-EOP-16-00
16
Operation, Calibration and Maintenance of Vibramax 110 vortexer
PCLPL-BA-EOP-17-00
17
Operation, Calibration and Maintenance of Multi Pulse Vortexer
PCLPL-BA-EOP-18-00
18
Operation and Maintenance of Nitrogen Generator
PCLPL-BA-EOP-19-00
19
Operation and Maintenance of Filtration Assembly
PCLPL-BA-EOP-21-00
20
Operation, Calibration and Maintenance of Column Oven
PCLPL-BA-EOP-22-00
21
Operation, Calibration and Maintenance of HPLC Systems
PCLPL-BA-EOP-23-00
22
Operation, Calibration and Maintenance of Incubator
Operation, Calibration and Maintenance of Spectrophotometer(Microplate
Reader)
Operation, Calibration and Maintenance of API 5500 Mass Spectrometer
PCLPL-BA-EOP-24-00
PCLPL-BA-EOP-27-00
27
Operation and Maintenance of Water Purification system (Micropore)
Operation, Calibration and Maintenance of Deep Freezer (Make: Haier
Medical and Laboratory Co. Ltd. Model No. 86L628)
Operation and Calibration of Fume Hood
28
Operation, Calibration and Maintenance of Conductivity Meter
PCLPL-BA-EOP-30-00
29
Operation, Calibration and Maintenance of API-3200 Mass Spectrometer
PCLPL-BA-EOP-31-00
23
24
25
26
PCLPL-BA-EOP-25-00
PCLPL-BA-EOP-26-00
PCLPL-BA-EOP-28-00
PCLPL-BA-EOP-29-00
Clinical SOP’s
Sr. No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
List of SOPs
SOP Title
Registration and Enrollment of Volunteer in Volunteer Database
Obtaining Informed Consent
Screening of Volunteer
Handling of HIV, HBsAg , HCV and VDRL Positive Volunteers
Transport of Biological Samples to the Pathology Lab and Obtaining Reports
Drug of Abuse
Receipt, Storage, Dispensing, Accountability and Disposal of Investigational Product
Initiation of Clinical Project
Project Master File
Conducting Clinical Examination and Vitals Signs
Duties of Custodian
Check-In and Check-Out
Serving Standardized Meals to Subjects
Phlebotomy Procedure
Dosing
Processing, Separation, Storage, Segregation and Transfer of Matrix
Transfer of Biological Samples to Bioanalytical or External Facility
Adverse Event Monitoring and Management
Handling of Subject Withdrawal and Dropout
Post Study Safety Assessment
Procedure for Blank Bio Matrix Collection
Management of Pharmacy
Transfer of Subject to Hospital
SOP No.
PCLPL-CL-SOP-01-00
PCLPL-CL-SOP-03-00
PCLPL-CL-SOP-06-00
PCLPL-CL-SOP-07-00
PCLPL-CL-SOP-08-00
PCLPL-CL-SOP-09-00
PCLPL-CL-SOP-10-00
PCLPL-CL-SOP-11-00
PCLPL-CL-SOP-12-00
PCLPL-CL-SOP-13-00
PCLPL-CL-SOP-14-00
PCLPL-CL-SOP-16-00
PCLPL-CL-SOP-17-00
PCLPL-CL-SOP-18-00
PCLPL-CL-SOP-19-00
PCLPL-CL-SOP-20-01
PCLPL-CL-SOP-21-00
PCLPL-CL-SOP-22-00
PCLPL-CL-SOP-23-00
PCLPL-CL-SOP-24-00
PCLPL-CL-SOP-25-00
PCLPL-CL-SOP-26-01
PCLPL-CL-SOP-27-01
Clinical SOP’s
Sr. No.
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
List of SOPs
SOP Title
Management of Emergency Care Unit (ECU)
Preparation of Clinical Summary Report
Conduct of Clinical Phase of BA-BE Project
Compilation of Project Documents
Labeling Procedure in Clinical
Pregnancy Test
Compensation to Subjects/volunteers During Clinical Phases At PCLPL
Management of Anaphylaxis
Management of Cardiac Arrest and Procedure for Cardio Pulmonary Resuscitation
Management of Nausea and Vomiting
Management of Hypoglycemia
Management of Convulsions
Management of Fever
Management of Headache
Premature Suspension or Termination of A Clinical Study
Handling of Reserved Subjects
Role and Responsibilities of Clinical Study Coordinator
Operation and Maintenance of Medical Assistance Alert System
Conduct of Double Blind Bioavailability/Bioequivalence Studies At PCLPL
Conduct of Concurrent Clinical Projects
Measurement of Height, Weight and Calculation of Body Mass Index of Volunteers
Conducting Medical Examination
Delegation of Responsibilities to Study Staff
SOP No.
PCLPL-CL-SOP-28-00
PCLPL-CL-SOP-29-00
PCLPL-CL-SOP-30-00
PCLPL-CL-SOP-31-00
PCLPL-CL-SOP-32-01
PCLPL-CL-SOP-33-00
PCLPL-CL-SOP-34-00
PCLPL-CL-SOP-35-00
PCLPL-CL-SOP-36-00
PCLPL-CL-SOP-37-00
PCLPL-CL-SOP-38-00
PCLPL-CL-SOP-39-00
PCLPL-CL-SOP-40-00
PCLPL-CL-SOP-41-00
PCLPL-CL-SOP-42-00
PCLPL-CL-SOP-43-00
PCLPL-CL-SOP-44-00
PCLPL-CL-SOP-45-00
PCLPL-CL-SOP-46-00
PCLPL-CL-SOP-47-00
PCLPL-CL-SOP-49-00
PCLPL-CL-SOP-51-00
PCLPL-CL-SOP-54-00
Clinical EOP’s
Sr. No.
List of SOPs
PCLPL-CL-EOP-03-00
2
SOP Title
Operation, Calibration and Maintenance of Centrifuge Machine (Make:
Heraeus & Model: Multifuge3S-R)
Operation, Calibration and Maintenance of Deep Freezer (-20ºc) (Make:
Labtop & Model: LBF 350VL
3
Operation and Maintenance of Ambu Bag
PCLPL-CL-EOP-05-00
4
PCLPL-CL-EOP-06-00
5
Operation, Calibration and Maintenance of Glucometer
Operation, Calibration and Maintenance of Stability Chamber {Make:
Thermolab )
6
Biometric Based Volunteer Management System
PCLPL-CL-EOP-08-00
7
Operation, Calibration and Maintenance of Suction Machine
PCLPL-CL-EOP-09-00
8
PCLPL-CL-EOP-10-00
10
Operation, Calibration
Operation, Calibration
system, Librar system
Operation, Calibration
Collo, Oxipod, Libra)
11
Operation and Calibration of Thermometer
PCLPL-CL-EOP-13-00
12
Operation and Calibration of Sphygmomanometer
PCLPL-CL-EOP-14-00
13
Online Volunteer Information System
Operation, Calibration and Maintenance of Defibrillator{Make: BPL
Model No: DF 2509/R}
PCLPL-CL-EOP-16-00
1
9
14
and Maintenance of Nebulizer
and Maintenance of Weighing Scale (Make: Eagle
& Electronic Kitchen Weighing SL-801)
and Maintenance of Height Scale (Make: SM
SOP No.
PCLPL-CL-EOP-04-00
PCLPL-CL-EOP-07-00
PCLPL-CL-EOP-11-00
PCLPL-CL-EOP-12-00
PCLPL-CL-EOP-17-00
Clinical EOP’s
Sr. No.
List of SOPs
15
SOP Title
Operation, and Maintenance of Cardiac Multiparameter Monitor {Make:BPL
Model:EXCELLO ECO}
PCLPL-CL-EOP-18-00
16
Operation, Calibration and Maintenance of Stability Chambers {Make: Visco}
PCLPL-CL-EOP-20-00
17
PCLPL-CL-EOP-22-00
21
Operation, Calibration and Maintenance of Digital Breath Analyzer Tester
Operation, Calibration and Maintenance of Cooling Centrifuge Machine (Make: Remi
and Model: C-30 and Make: Remi and Model: C-30 BL)
Operation, Calibration and Maintenance of Deep Freezer (Make: Electrolux and
Model: EC-1109)
Operation, Calibration and Maintenance of Centrifuge Machine (Make: Heraeus and
Model: Heraeus Megafuge 16R)
Operation, Calibration and Maintenance of Deep Freezer (-20°C) (Make: Haier and
MODEL: DW- 40L508)
22
Operation, Calibration and Maintenance of Refrigerator
PCLPL-CL-EOP-28-00
23
Operation, Calibration and Maintenance of Pipette
PCLPL-CL-EOP-29-00
24
Operation, Calibration and Maintenance of ECG Machine
PCLPL-CL-EOP-30-00
25
PCLPL-CL-EOP-31-00
27
Operation, Calibration and Maintenance of Pulse Oximeter
Operation, Calibration and Maintenance of Defibrillator (Make-MEDTRONIC, ModelLIFEPAK CR PLUS)
Operation, Calibration and Maintenance of Cardiac Bedside Monitor {Make: BPL
Model}
28
Operation, Maintenance of Labeling Printer (Make : CITIZEN and Model : CL-S700)
PCLPL-CL-EOP-35-00
18
19
20
26
SOP No.
PCLPL-CL-EOP-23-00
PCLPL-CL-EOP-24-00
PCLPL-CL-EOP-26-00
PCLPL-CL-EOP-27-00
PCLPL-CL-EOP-33-00
PCLPL-CL-EOP-34-00
List of SOPs
Medical Writing SOP’s
Sr. No.
1
2
3
4
5
6
SOP Title
Initiation, Preparation, Review, Approval and Distribution of BA/BE and
Related Study Protocols
Preparation, Review and Distribution of Informed Consent Form
Translation and Back Translation of Informed Consent Form (ICF)
Preparation and Completion of Case Record Form
Submission of Documents to Ethics Committee
Communication to Regulatory Authority
SOP No.
PCLPL-MW-SOP-01-00
PCLPL-MW-SOP-02-00
PCLPL-MW-SOP-03-00
PCLPL-MW-SOP-04-00
PCLPL-MW-SOP-05-00
PCLPL-MW-SOP-06-00
7
Preparation of Final Report
PCLPL-MW-SOP-07-00
Statistical SOP’s
Sr. No.
1
2
3
4
5
SOP Title
Sample Size Calculation for BA/BE Studies
Randomization
Detection of Statistical Outlier
Statistical Analysis Using SAS 9.3 Or Higher Version
Calculation of Pharmacokinetic Parameters Using SAS ® Software Version
9.3 For BA/BE Studies
SOP No.
PCLPL-PK-SOP-01-00
PCLPL-PK-SOP-02-00
PCLPL-PK-SOP-03-00
PCLPL-PK-SOP-04-00
PCLPL-PK-SOP-05-00
List of SOPs
Quality Assurance SOP’s
Sr. No.
SOP Title
SOP No.
1.
Scheduling of Audit Activities for a Study
PCLPL-QA-SOP-01-00
2.
Conducting Audits of Clinical Department
PCLPL-QA-SOP-02-00
3.
Conducting Audits of Bioanalytical Department
PCLPL-QA-SOP-03-00
4.
Preparation and Release of Audit Report
PCLPL-QA-SOP-04-00
5.
PCLPL-QA-SOP-05-00
6.
Audit of Final Project Report
QA Line Clearance for Investigational Product Receipt, Dispensing
and Destruction Procedure
7.
Auditing of Vendor Facilities
PCLPL-QA-SOP-07-00
8.
System Audit at PCLPL
Identification of Non-Conformance and Implementation of
Corrective Action and Preventive Action Plan
PCLPL-QA-SOP-08-00
9.
PCLPL-QA-SOP-06-00
PCLPL-QA-SOP-09-00
List of SOPs
Administration SOP’s
Sr. No.
SOP Title
SOP No.
1
Purchase, Issue of Items
PCLPL-AD-SOP-01-00
Information Technology SOP’s
Sr. No.
SOP Title
SOP No.
1
Computer User ID and Password
PCLPL-IT-SOP-01-00
2
Computer Data Backup
PCLPL-IT-SOP-02-00
Manuals / Policies
Site Master File
Quality Manual
Safety Manual
IT Policies
Regulatory submissions
BA/BE Studies
• More than 900 studies
USFDA submission:
Successfully audited for Atazanavir + Ritonavir
• Zolmitriptan
• Atazanavir + Ritonavir
• Iron Sucrose
• Dapsone
• Dutasteride
• Paricalcitol
• Leucovorin
Regulatory submissions
EMEA submission:
• Metformin
• Clopidogrel
• Olanzapine
MHRA – UK:
• Alverine Citrate
MCC – South Africa:
• Levonorgestrel
WHO :
• Atazanavir + Ritonavir
TGA – Australia:
• Clopidogrel
HSA - Singapore:
• Glipizide
Regulatory Approvals
Facility Approval
Study Approval
DCGI - India
MOH - Turkey
FDA - USA
MHRA - UK
MCC - South Africa
MOH - Malaysia
MOH - Kazakhstan
HSA - Singapore
TGA – Australia (awaited)
Clinical Trials
• Phase II – USFDA submission
NCE for Type II diabetes patients conducted in-house
• Phase II – USFDA submission
NDDS formulation for patients infested with Head Lice
conducted in-house
• Phase II-A – Australian TGA submission
NCE for patients infested with Head Lice conducted in-house
• Phase I – DCGI & USFDA submission
NDDS formulation for breast cancer patients conducted at 5
hospital sites
Clinical Trials
• Phase II – USFDA submission
Dermatology (patients with Tinea Pedis)
• Phase III – Kazakhstan submission (2 studies)
Bacterial infection (antibiotics)
• Phase III – Awaiting local regulatory permission for three
Clinical Trials.
* (DMRI) Panexcell is already listed on the USFDA Clinical Trial Registry
for Dermatology Clinical Trials
Thank you
Panexcell Clinical Lab Private Limited
(Formerly known as Drug Monitoring Research Institute (P) Ltd.)
Contact:
R-374, TTC MIDC, Rabale,
Navi Mumbai – 400701 India.
Tel.: +91 22 3969 7979
Fax: +91 22 3969 7999
E-mail: [email protected]
Website: www.panexcell.com