Field Phas Sub phases Input Output No of Duration on-site Off Site Concerned Steering

e Data Data Experts (Hours) mission mission staff committee

( Vegas Days Days
CG)
API Q1 Complete Directors
Gap Analyis Compliance QMR
Stage Matrix 2 8 3 0 Departments
2 (Diagnosis) Compliance Heads
Matrix Employers
Complete inventory of
Actions plan Compliance compliance actions QMR
Matrix Direction
Stage Complete Prsentation of 2 8 4 2 QMR
3 Restitution Compliance gaps Concerned
Matrix Departments
Heads
Quality Direction
management QMR
training, API Q1 Departments
, SPEC 10A 1 8 5.5 0 Heads
Stage Audit Training, Employees
4 API Q1
API depending on Tranning Group will be
Q1 the joined plan formed during the
project Execution
Standard
Training in Existing documents
writing document Quality manual
operational format Processes
Stage documents Procedures
5 API Instructions of 3 8 5 40 QMR
requirements work, technical
to specifications Departmental
and operating Heads
Stage modes
7 Records and
dashboards
support for Approved QMR
drafting documents 5 3 3 Departmental
operational Heads
documents employers
 Writing the Quality manual 0 0 QMR
quality manual written in English 3

Following up
the post audit
setting up Internal audit actions QMR
internal audit procedure Qualification of
processes API Internal audit the internal
Q1 planning auditors
Stage Management Process Management 2 8 2 0 Direction
8 review process review review report QMR
Performance Decision on
indicators quality
Normative management
requirements

8 QMR
Pre audit API Q1 Audit report 3

Definition of Audit report Actions plan

Stage compliance 3 8
9 actions
Applicant forms in NO of Days to
To Preparation of Required English Decided Upon Out of
the documents documents by the Quality manual in 3 8 Stage 8
Stage to be provided API English
11 to the API Compliance matrix
in english
 Plan elaboration Inventory of Detailed plan
actions to be (who did what for
Stage implemented for when)
1 API spec 10A Identification of the
certification needed trainees
To Following up of 2 8 3 0
the Detailed plan General
Stage implementation Improvements
4 /planned

Process Interlinking 2 2 2
API Mapping manufacturing
Spec process to
10A Standard
Training in the Format of existing documents
drafting of documents Product
professional Requirements description
documents API Q1 sheets
Stage Quality
5 document 3 8 2.5 0
Methods to
evaluate and
control the
product
conformity in
the laboratory
and the API
Support for the Documents to be Approved 5 5 5
drafting of approved documents
professional
documents
Pre Pre audit API spec 10A Audit report integrated integrated
audit definition of Audit report Actions plan integrated integrated
QMS compliance 2 4
actions
preparation of Required Applicant forms in integrated integrated
the documents documents by the English
to be provided API
to the API

Off-site Off-site
mission mission