Gap analysis to comply revised schedule M

Page 1 of 12

Gap analysis to comply revised schedule M Quality Management System (QMS)

S. Quarter
Existing Time lines for
No. Revised schedule M Gap/Remarks wise Justification
Schedule M completion
Execution
Assessment of Current Pellets Sections Quality
Practices: QMS that will be Management System
implemented throughout (QMS) implementation
mfg. through the different of revised SOP, manuals
stages of a product PQR, Q3
lifecycle.QMS manual (JUL - SEP 2025) To establish
preparation Hence Comprehensive
formulation development, (Separate SOP Not QMS with QRM
Quality drug manufacturing , and available) and PQS for the
Management above said
Comprehensive QMS with retention of documentation,
1. System (QMS) quality control, change implementation and
QRM and PQS.
Basic QMS management system, CAPA Hence a time line
requirements. system, etc system APQR implementation till December 2025
establishment & Trainings. of revised SOP. is required which is
Different aspects of product (JUL-SEP 2025) justified by the
Q3
development and management.
manufacturing will be (As per QA/017 SOP)
implemented as per the QMS
via PQS, QRM.

The Revised Schedule

M outlines specific HVAC, To implement
clean room classification, and Facility &
Facility Facility& Equipment air flow requirements for Pellets section Facility Equipment Design
pharmaceutical facilities, & Equipment Design above said
Equipment Design emphasizing the need for
Design Detailed HVAC ,clean dedicated HVAC systems, Up gradation implementation and
2. room
General hygiene HEPA filtration, and (JUL - SEP 2025) Q3 Hence a time line
and Classification ,air flow controlled environmental till September 2025
layout requirements parameters like temperature, (SOP Not available) is required which is
humidity, and differential justified by the
pressure. Shall be maintained. management
Hence Up-gradation of
 Gap analysis to comply revised schedule M
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Gap analysis to comply revised schedule M Quality Management System (QMS)

S. Quarter
Existing Time lines for
No. Revised schedule M Gap/Remarks wise Justification
Schedule M completion
Execution
AHU/HVAC is planned as
relevant in all 4 sections
regular maintenance and
validation of these systems.
Enclosures will be upgraded
skinned, corrosion-resistant,
and include thermal and
insulation. HEPA will be
relocated to terminal in 2
manufacturing sections.
Protocols Preparation To implement
and resources Robust control and
Q3 risk-based cleaning
mobilization.
(JUL - SEP 2025) validation above
Contamination Contamination Control Cross-contamination said implementation
3. Control Robust control and risk- Robust control and risk- Equipment surface area and Hence a time
Basic guidelines based cleaning validation based cleaning validation calculations & Pre- line till December
validations & cleaning 2025 is required
Q3 & Q4
Method validations. which is justified by
Activity executions the management.
(JUL-DEC 2025)
Protocol preparations & To implement risk-
Training Q3 based Process
(JUL - SEP 2025) validation above
Process Process Validation Validation Execution said implementation
Validation 6 products risk-based
4. Minimal Mandatory risk-based (OCT-DEC 2025) and Hence a time
validation validations will be planned
requirement (As per QA/016 SOP line till December
Q4
but separate SOP Not 2025 is required
available for Process which is justified by
validation) the management
 Gap analysis to comply revised schedule M
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Gap analysis to comply revised schedule M Quality Management System (QMS)

S. Quarter
Existing Time lines for
No. Revised schedule M Gap/Remarks wise Justification
Schedule M completion
Execution
To implement
Protocols will be Cleaning validation
prepared Q3 above said
(JUL - SEP 2025) implementation and
cleaning validation & Hence a time line
Cleaning till December 2025
Validation Cleaning Validation Cleaning validation protocols cleaning Method
5. Mandatory for all validation Work is required which is
Not specifically equipment and Products preparation justified by the
addressed completion will be done Q3 & Q4
by (OCT-DEC 2025) management.
(As per QA/016 SOP
but separate SOP Not
available for cleaning
validation)
To implement
This validation process Method validation
Preparation of Protocols.
should include steps like Q3 above said
Analytical (JUL - SEP 2025)
defining the scope, implementation and
Method Analytical Method identifying parameters,
Validation Validation Hence a time line
6. determining acceptance Training and execution
Not specified Detailed expectations as till December 2025
criteria, and demonstrating of Validation/
clearly per ICH guidelines Q3 & Q4 is required which is
the method's suitability for Verification of methods
justified by the
its intended use in the about 6 nos
management.
respective Protocols . (JUL- DEC 2025)
(SOP Not Available)
Risk Assessment: To implement
A thorough risk assessment Change control
Change Control should be conducted for each Trainings, Risk
Change Control System Q3 procedures above
System proposed change as relevant assessment
7. Documented procedures said implementation
Informal or ad to identify potential negative (JUL - SEP 2025)
with risk assessment and Hence a time
hoc. impacts on product quality, line till December
safety, and efficacy. Hence 2025 is required
 Gap analysis to comply revised schedule M
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Gap analysis to comply revised schedule M Quality Management System (QMS)

S. Quarter
Existing Time lines for
No. Revised schedule M Gap/Remarks wise Justification
Schedule M completion
Execution
SOP change, Trainings, Risk Documentation & Risk
assessment communication Identification aspects
and Protocols and
Documentation: execution.
which is justified by
Should be thoroughly Q3 & Q4
(JUL-SEP 2025) & the management.
documented. Risk
Identification aspects and
Protocols / Reports and (OCT– DEC 2025)
execution
(As per QA/004 SOP)
Central Drugs Standard
Control Organization To implement
Guidance Document Complaint & Recall
(Distribution, complaints and SOP
Recall
preparation, Mock
& Training upgraded procedure
Complaint & Complaint & Recall product recall: (a) Resource identification above said
Recall arrangements and recording and mobilization
8. Robust SOPs, traceability, system for distribution; (b) Q3 implementation and
Basic mention and RCA Arrangements for the (JUL - SEP 2025) Hence a time line
handling of complaints and (As per QA/022 SOP) is required which is
product recalls) shall be justified by the
implemented Document No. management
IMP/REG/200711
Training as per the revised PQS Q2 To implement
Schedule M guidelines Trainings as per
compliance with updated (APR-JUN 2025) revised schedule-M
Personnel Personnel Training Good Manufacturing above said
9. Training Structured training with Practices (GMP)
General mention documentation QRM implementation and
standards. The revised Hence a time line
Schedule M emphasizes a Q3 till December 2025
Pharmaceutical Quality (JUL-SEP 2025)
is required which is
 Gap analysis to comply revised schedule M
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Gap analysis to comply revised schedule M Quality Management System (QMS)

S. Quarter
Existing Time lines for
No. Revised schedule M Gap/Remarks wise Justification
Schedule M completion
Execution
System (PQS) and requires
continuous improvement in Others
training programs. This
includes training on quality (OCT-DEC 2025) Q4
justified by the
risk management,
management
documentation, data (As per QA/009 SOP)
integrity, and more.
10. QA Unit QA Unit The QA role, as per the SOP shall be revised Q2 To implement
Not clearly QA oversight on batch revised Schedule M (Quality assurance role) Roles as per
defined release, deviation, CAPA guidelines, focuses on PQS establishment & PQS Revised schedule-
ensuring product quality and Implementation. implementa- M above said PQS,
safety throughout the
pharmaceutical (As per QA/004, tion Q3 QRM, Data
manufacturing process. This QA/011, QA/012 Integrity
includes implementing a SOP’s) QRM implementation and
robust Pharmaceutical &Data Hence a time line
Quality System (PQS), Integrity till December 2025
conducting periodic quality audits is required which is
reviews, and securing senior compliance, justified by the
management commitment to Training management.
quality standards. QA also
plays a crucial role in risk etc.
management, data integrity, , Q4
facility validation,.
Here's a more detailed
breakdown of the QA role:
1. Implementing a (PQS):
(Revised GMP): (QRM):
QA implements systems as
per QRM at each stage of
manufacturing.

Data Integrity :(ALCOA+).

Product Quality Review:
 Gap analysis to comply revised schedule M
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Gap analysis to comply revised schedule M Quality Management System (QMS)

S. Quarter
Existing Time lines for
No. Revised schedule M Gap/Remarks wise Justification
Schedule M completion
Execution
QA conducts regular PQR
identify areas for
improvement and ensure
consistent quality.
250 starting material To implement Risk
suppliers (i.e., based assessments
manufacturers) shall be on all above
initially qualified on the mentioned Risk
The revised Schedule M
basis of documented aspects
guidelines emphasize a risk-
criteria and a risk-based implementation and
based approach to Good
approach QRM Hence a time line
Manufacturing Practices
implementation will be till December 2025
Risk-Based Approach (GMP), focusing on
Risk-Based planned is required which is
QRM mandatory in all identifying, assessing, and
Approach Pharmaceutical quality justified by the
11. critical activities mitigating risks throughout
system (PQS) Q2, Q3 & management.
Not included the pharmaceutical
(SOP Not available) Quality risk
lifecycle. This approach aims
management (QRM) Q4
to enhance patient safety,
Product quality review
product quality, and
(PQR)
regulatory compliance.
Qualification and
validation
Implementation of a
computerized storage
system implementation
12. Batch Batch Production Systematic approach To implement
Production Record Batch production records. that includes Quality Comprehensive
Record Comprehensive BMR, Verification shall be done Risk Management
format shall be included (QRM), Data Integrity BMR format
Basic batch with following against master production and ALCOA+ changes with QA
documentation instruction. Reference to the compliance for review above said
Storage Conditions: The current master production Documents. Q4 implementation and
recommended storage instruction. Hence a time line
conditions for the raw These records shall be till December 2025
 Gap analysis to comply revised schedule M
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Gap analysis to comply revised schedule M Quality Management System (QMS)

S. Quarter
Existing Time lines for
No. Revised schedule M Gap/Remarks wise Justification
Schedule M completion
Execution
is required which is
(OCT- DEC 2025) justified by the
management.
(SOP not available)
numbered with a unique
materials and finished batch identification number,
products reprocessed materials used
License number. during manufacturing; Identify potential risks
 Process Parameters: critical process parameters; at each stage of the
Detailed information (v) any sampling performed; manufacturing process,
about the manufacturing (vii) in-process and from raw material to
process, including laboratory test results; finished product
temperatures, Humidity (viii) actual yield at Q3 & Q4
etc appropriate phases or times; Revised BPR shall be
(ix) description of packaging implemented. Product
specific BPM shall be
and label (x) representative prepared
label commercially available;
(xii) results of release testing
( JUL-SEP 2025)

(OCT-DEC 2025)
 Gap analysis to comply revised schedule M
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Gap analysis to comply revised schedule M Quality Management System (QMS)

S. Quarter
Existing Time lines for
No. Revised schedule M Gap/Remarks wise Justification
Schedule M completion
Execution
DM Water system: up -gradion of
Current system is referenced water system &
to IP monograph compliant work orders and
Purified water system
water system. WHO Good the Re-validation
up-gradation to meet
manufacturing practices:
besides
water for pharmaceutical use, TRS 970 Annex -3 Q3
WHO Technical Report guidance time lines environmental
Series, No. 970, Annex 3, (JUL - SEP 2025) control up-
DM Water compliance work is in gradation does
system: DM Water system: progress. Purification take the time till
For core special note of TRS- systems Water storage and December 2025
manufacturing WHO implementation, distribution systems is justified
area pellets Water constraint the sanitization and bio-burden
having DM water manufacturers to made control, Storage vessels. Implementation of
IP specification mandatory, water Water Maintenance of water revised SOP, Log
13. was mandatory. generation system, systems. System reviews books templates & Q2
But, the DM storage tanks, re- Inspection of water systems Protocols, Records
water generation circulation, pumping, now become part of revised (APR - JUN 2025)
system, storage, treatment of water, etc as system. To
and circulation par with current TRS of comply the above we have
were not address WHO. planned to revise the
in depth. following
1. SOP, Log books/Other Water system 2 phase
records validation to be
Protocols:-System carried out after up- Q3 & Q4
components up- gradation gradation
&Water system re validation. (JUL – DEC 2025)
Temperature monitoring (As per EM/004
shall be monitored with SOP)
evidence
 Gap analysis to comply revised schedule M
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Gap analysis to comply revised schedule M Quality Management System (QMS)

S. Quarter
Existing Time lines for
No. Revised schedule M Gap/Remarks wise Justification
Schedule M completion
Execution
Environment
Implementation of
control: For core
revised SOP, Log books
manufacturing
Environment control: templates &
area of pellets and
For core manufacturing AHU-Protocols,
external Q2
area of pellets and drawings & Records
manufacturing
external manufacturing (APR-JULY 2025)
area, AHU was
area, AHU is mandatory. Environment control:
mandatory. But,
CLASS-D classification is Production do have HEPA 5 (SOP Not Available)
Final filter to
made mandatory. Final and 0.3 micron filters in
14. blow air in the
filter to blow air in the plenum AHU. Hence we will
core room, was
core room, should be Install 0.3-micron HEPA AHU-Requalification &
having 5-micron
having 0.3-micron HEPA filters at terminal side. Validation Purchase
filters. 5-micron
filters. 0.3-micron HEPA Orders Issuance and
filters, installed at
filters, should be installed Q3 & Q4
terminal or activity completion
at terminal side only, not
plenum, were
at plenum side.
adequate. No (AUG –DEC 2025)
classification was
mandatory
Cross- Cross-contamination:
contamination: For core manufacturing Providing air
URS will be issued
For area, Separate material locks preventive
Purchase /work Order
manufacturing transfer airlocks and to cross-
MATERIAL TRANSFER issuance to vendors.
area, Separate men entry airlocks are contamination
AIRLOCKS will be
material transfer made mandatory. Re-validation of
15. provided in Production Activity Completion Q3
airlocks and Both MAL and PAL are AHUs &
sections. Pass boxes will
men entry made mandatory with Drawings does
be provided (MAL) (JUL –SEPT 2025)
airlocks were classification having take the time till
not mandatory. CLASS-D. December 2025 is
(SOP Not Available)
pass-box If pass-box are justified.
 Gap analysis to comply revised schedule M
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Gap analysis to comply revised schedule M Quality Management System (QMS)

S. Quarter
Existing Time lines for
No. Revised schedule M Gap/Remarks wise Justification
Schedule M completion
Execution
provided were provided, they are made
not made mandatory with
mandatory with classification. Pass box
classification. between two rooms
No classificationhaving same CLASS-D
was mandatory. qualification, may be
static pass-box.
But, pass-box between
two rooms having
different classification
(i.e. between Classified
area and Non-Classified
area), should be with
dynamic system
(Having 0.3-MICRON
HEPA filter).
16. Qualification Qualification and Qualification over all Qualification Qualification
and Validation Validation Product equipments will be Protocols will be equipments will
Product process validation planned prepared & Activity Q3 be planned &
process Newly Added. Detailed completion completed by Q4
validation requirements of (JUL –SEPT 2025) & Validation
These equipment qualification Validation Product Product process
requirements are along with process process validation will be Validation Protocols validation is time
specified with validation are specified. done. will be prepared consuming
minimum In revised Schedule M, (JUL –SEPT 2025) activity , Hence a
emphasis. six another 5 categories are time line till
product specific added. Total 11 product Process validation December 2025 is
Q3
manufacture specific manufacture Work completion will required which is
requirements are requirements are be done by justified by the
 Gap analysis to comply revised schedule M
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Gap analysis to comply revised schedule M Quality Management System (QMS)

S. Quarter
Existing Time lines for
No. Revised schedule M Gap/Remarks wise Justification
Schedule M completion
Execution

(OCT-DEC 2025)
management
specified. specified.
Q4 conclusion
(As per QA/016)

Self-inspection, Self-inspection,
quality audits Quality audits at
quality audits and
and suppliers’ Quality audits planning & vendors planning
suppliers’ audits and
audits and communication to vendor. & communication
approval (OCT-DEC 2025)
approval Vendor questionnaires to vendor. Vendor
This activity is more
shall be obtained. questionnaires
17. clarified and extended Q4
(As per QA/007) shall be obtained.
The activity is beyond self-inspection
Schedule prepared
limited up to towards supplier
which does take a
internal approval through
time line till
inspection quality audits of his
December 2025.
premises and processes.
ALCOA is a set
SOP’s & ALCOA
ALCOA for data Q2 of 5 data integrity
Documentation Documentation check list
integrity shall be principles, crucial
General Specific requirements (APR-JUN 2025)
implemented following for maintaining
principles of are mentioned as per data quality in
documents shall be
18. good ALCOA principles GMP. It Important
prepared
documentation from global standards. (JUL-SEP 2025) Q3 to Validation and
1 SOP’s
practices and ALCOA: – Data Integrity.
2 ALCOA check list
electronic Attributable, Legible, ALCOA techniqu
e can provide an
 Gap analysis to comply revised schedule M
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Gap analysis to comply revised schedule M Quality Management System (QMS)

S. Quarter
Existing Time lines for
No. Revised schedule M Gap/Remarks wise Justification
Schedule M completion
Execution
documents were Contemporaneous, ALCOA related internal audit trail that
mentioned. Original and Accurate. audits at QA/QC captures details
departments to understand such as additions,
the gaps. . Deficiencies (OCT-DEC 2025) deletions, (or)
identification will be done. Q4 alterations of
(SOP Not available) information in an
Compliance to deficiencies electronic record.
of ALCOA and imparting Hence it will take
training/retraining a time line till
December 2025

Note: Schedules divided in to 3 quarters for execution Q2, Q3, Q4.

Q2 (APR-JUNE 2025)
Q3 (JULY –SEP 2025)
Q4 (OCT- DEC 2025)