M.

Ali Sheikh
Designation : Internee
QA lab compliance
(Stability)
Getz Pharma (Pvt)Ltd
 Compliance
R&D
(AL)

Stability Compliance QC lab1

QC lab2
 Compliance

R&D(AL), Zulfiqar Ali M. Ali

Stability and (Associate sheikh
Microbiology Manager) (Internee)

QC lab 1 (SFG, Tanveer Irshad Alam Kanwal

FG, Packaging Memon (Associate Hussain
and Validation) (Manager) Manager) (Executive)

QC lab 2 (Raw Afsheen

materials and Hussain
MDIs) (Manager)
 Compliance

Auditing of
documents

Software
Data Integrity Compliance compliance

OOS/OOT
 Compliance
Data integrity:
The degree to which all data is completed. In data integrity we use
ALCOA principles.

A Attributable Who did it?

L Legible
Easily readable and
permanently record

C Contemporaneous
Done in real time or
not

O Original Original or true copy

A Accurate Accurate and precise

 Compliance

User Creation and

set level of
authorization

Review of Audit Software Security policy and

trial and log data
browse compliance backup/restoration

Set and Fixed

Integration
Parameters
 Compliance
Software compliance:
 Fixed and locked methods
◦ Ensure the method parameters as per Method validation and
TAP.
 Security policies:
◦ Audit trail enable, user creation, password, prohibit delete etc.
 Data backup:
◦ On daily basis.
 Level of privileges
◦ Administrator
◦ Chemist
◦ Analyst
◦ Method developer
◦ Guest
◦ Vendor
 Compliance

Issuance of PLIR
Number

Tracking and Conduct

trending of OOS OOS/OOT investigation for
with pareto analysis
in order to reduce investigation root cause
evaluation
invalid OOS.

Documentation
along with CAPA.
 Compliance

Stability protocol,
Reports along with
AR and log books
and stability data

Auditing of
NRFT tracking and documents
trending along with as per Training records
CAPA to reduce
the no. of NRFT ALCOA
principle

Calibration
certificates
 Suggestions
 Link HPLCs and balances directly with
SAP.
 More hiring in compliance for review of
documents with complete traceability.