Getz Pharma

M. Ali Sheikh Designation : Internee QA lab compliance (Stability) Getz Pharma (Pvt)Ltd

Compliance R&D (AL)

Stability

Compliance

QC lab2

QC lab1

Compliance R&D(AL), Stability and Microbiology

Zulfiqar Ali (Associate Manager)

M. Ali sheikh (Internee)

QC lab 1 (SFG, FG, Packaging and Validation)

Tanveer Memon (Manager)

Irshad Alam (Associate Manager)

QC lab 2 (Raw materials and MDIs)

Afsheen Hussain (Manager)

Kanwal Hussain (Executive)

Compliance Auditing of documents

Data Integrity

Compliance

OOS/OOT

Software compliance

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 trial and log browse

Software compliance

Set and Fixed Integration Parameters

Security policy and data backup/restoration

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 trending of OOS with pareto analysis in order to reduce invalid OOS.

OOS/OOT investigation

Documentation along with CAPA.

Conduct investigation for root cause evaluation

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

NRFT tracking and trending along with CAPA to reduce the no. of NRFT

Auditing of documents as per ALCOA principle

Calibration certificates

Training records

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