Quality Manual

QUALITY MANUAL

Pharmaceutical Quality System for the Manufacture of Primary Packaging Materials

Hoera, Mogra, Hooghly, West Bengal – 712147

Document No. SIPL/QMS/001

Version 00

Next Review Date 04.07.2028

Framework ICH Q10 (§1.8 quality manual content), ISO 15378:2017, ISO 9001:2015, applicable cGMP for primary packaging materials, IS 15392 & IS 16011

Supersedes None (first issue of Quality Manual)

+------------------------+------------------------+------------------------+ | | | | | Name: | Name: | Name: | | ______________________ | ______________________ | ______________________ | | | | | | Designation: | Designation: | Designation: | | ________________ | ________________ | ________________ | | | | | | Sign / Date: | Sign / Date: | Sign / Date: | | ________________ | ________________ | ________________ | +========================+========================+========================+

TABLE OF CONTENTS

1. Introduction and Company Profile

2. Scope of the Quality Management System

3. Quality Policy

4. Quality Objectives

5. Organisation, Responsibilities and Independence of Quality

6. Management Responsibility

7. Documentation System, GDP and Data Integrity

8. Training, Competency, Hygiene and Health

9. Premises, Infrastructure and Contamination Control

10. Equipment, Calibration and Maintenance

11. Supplier Qualification and Purchasing Controls

12. Material Management

13. Production and In-Process Controls

14. Printed Packaging Material Controls, Traceability and Reconciliation

15. Quality Control, OOS and Batch Release

16. Validation and Qualification Governance

17. PQS Elements: Monitoring, CAPA, Change Management, Risk and

Knowledge Management

18. Complaints, Returns, Recall and Customer Notification

19. Internal Audit and Self-Inspection

20. Management Review and Continual Improvement

21. Record Retention and Archival

22. Customer-Specific Quality Requirements

23. References and SOP Cross-Reference

24. Revision History and Annexures

1.0 INTRODUCTION AND COMPANY PROFILE

(established 1996; group turnover above ₹10,000 crores; Government of India 4-Star Export House), operates an integrated aluminium foil conversion plant at Hoera, Mogra, Hooghly District, West Bengal (established 1960 as India Foils Ltd., later Ess Dee Aluminium Ltd., acquired by the Group in 2022 and substantially revamped). The site manufactures plain, coated (VMCH/HSL blister), poly-laminated (strip) and gravure-printed aluminium foil, 9–60 micron, used as primary packaging in direct contact with medicinal products, and for food and FMCG packaging. This Quality Manual defines the site's Pharmaceutical Quality System (PQS): its philosophy, scope, governance, processes and interrelationships, in the format contemplated by ICH Q10 §1.8, and constitutes the top-level document of the quality documentation hierarchy.

2.0 SCOPE OF THE QUALITY MANAGEMENT SYSTEM

The QMS applies to all activities at the Hoera site affecting the quality of aluminium foil packaging materials: order receipt and review; procurement and vendor qualification; receipt, storage and issuance of materials; rewinding, rolling, separation, annealing, coating, lamination, printing, doctoring, slitting and packing; in-process and final quality control; batch release and COA issuance; warehousing, dispatch and distribution; complaints, returns and recall support; and all supporting quality-system processes. Standards followed: ISO 15378:2017, ISO 9001:2015, ICH Q10 principles, applicable cGMP expectations for primary packaging material manufacturers, and BIS standards IS 15392 (food-grade foil) and IS 16011 (pharma-grade foil). Exclusions: design and development of medicinal products; sterile manufacturing; product (pack) performance validation, which is performed by customers on customer-specific products. Environment, health & safety and HR are managed through dedicated procedures (SIPL/QAS/022–028 series) integrated with, but subordinate to, product-quality requirements.

3.0 QUALITY POLICY

“We are committed to delivering premium-grade, defect-free aluminium foil products that consistently meet or exceed customer and regulatory requirements. We achieve this through continuous improvement, employee development, and strict adherence to global safety and quality standards.”

For pharmaceutical primary packaging, this commitment specifically includes: manufacture under GMP conditions appropriate to product-contact materials; protection of foil from contamination and mix-up; integrity and accuracy of printed text; full batch traceability; and honest, data-driven representation of quality status to customers and auditors. The policy is communicated to all employees and contract workers through induction and displayed at site; it is signed and dated by top management per SIPL/QAS/001 and reviewed for continuing suitability at management review.

4.0 QUALITY OBJECTIVES

Achieve ≥ 98 % on-time delivery;
Maintain a customer defect (complaint) rate below 1.0 %;
Continually minimise waste through efficient scrap management and recycling;
Zero critical audit findings on data integrity, traceability and printed-material control;
Complete the qualification/validation programme per the VMP schedule (SIPL/VMP/001).

Objectives are quantified, assigned and tracked per SIPL/QAS/026 (Management Objectives) and reviewed at management review with actions where trends are adverse.

5.0 ORGANISATION, RESPONSIBILITIES AND INDEPENDENCE OF QUALITY

The organisation chart (SIPL/OC/001) defines reporting lines from the Plant Head (Mr. Dilip Santra) across Production, Quality, Plant Engineering, Warehouse, PPC, Commercial/Purchase/Export, HR, IT, Accounts and Security. To preserve the impartiality of quality decisions, the Head – Quality (Mr. Sekhar Sengupta) owns the QMS and reports directly to the Managing Director — independently of the Plant Head and site operations — with documented authority to: approve/reject raw materials, packing materials, intermediates and finished goods; release batches for dispatch; approve quality documents; stop production or dispatch; approve vendors; and represent quality to customers and auditors. QA (Mr. Rohit Kr. Das) manages document control, change control, deviations/CAPA, training coordination and batch record review; QC (Mr. Manish Parihar) manages testing, calibration and COA issuance. In the absence of the Head – Quality, batch-release and quality-decision authority is delegated to the QA In-charge per a defined delegation matrix.

6.0 MANAGEMENT RESPONSIBILITY

Site and group management demonstrate commitment to the PQS by: establishing the quality policy and objectives; providing resources (competent personnel, equipment, the ISO 8 cleanroom investment, external expertise); assigning authorities and safeguarding the independence of the Quality function, which reports to the Managing Director; conducting management reviews per SIPL/QAS/019; internal communication of quality performance; managing outsourced activities and purchased materials through SIPL/QAS/007 and defined arrangements; and ensuring continuity of the quality system through changes in product or site ownership (as demonstrated during the 2022 acquisition, where the quality system has been rebuilt and re-documented under the SIPL/QAS framework). Participation and consultation of personnel is per SIPL/QAS/027; legal and other requirements are identified and tracked per SIPL/QAS/023.

7.0 DOCUMENTATION SYSTEM, GDP AND DATA INTEGRITY

Document hierarchy (top-down): Level 1 — this Quality Manual (SIPL/QMS/001); Level 2 — Site Master File (SIPL/SMF/001) and Validation Master Plan (SIPL/VMP/001); Level 3 — SOPs and Standard Test Methods (111 documents indexed in SIPL/QAS/001/F05: PDI, PDS, QCS, QCI, QAS, STM, WHS, SAS, PUS, ENI, ENS and HRS series); Level 4 — formats, records, registers, logbooks, batch records, COAs. Documents are prepared, reviewed, approved, issued, distributed and retired per SIPL/QAS/001, revised only through change control (SIPL/QAS/002), and reviewed at least every two years. This manual supersedes the legacy SIPL-QM-18 on approval.

Good Documentation Practice per SIPL/QAS/017: entries are contemporaneous, legible, indelible, attributable (sign & date), with single-line error correction (no overwriting/whiteners), controlled integrity per SIPL/QAS/030 applies ALCOA+ to paper and electronic records: unique attributability, original-record retention, access control on computerised systems, backup, prohibition of unofficial 'rough' records for GMP data, and periodic self-inspection of data practices. Blank controlled formats are issued and reconciled by QA. The site uses a SAP/ERP system for stores, material and inventory transactions supporting batch traceability.

8.0 TRAINING, COMPETENCY, HYGIENE AND HEALTH

Training per SIPL/QAS/003 covers GMP/hygiene induction for all staff and contract workers, SOP-specific training with read-and-understood sign-off before independent working, on-the-job qualification for operators, refresher training and effectiveness checks; records are retained per employee. A plant-wide training exercise on all applicable SOPs, with attendance and sign-off records is available. Personnel health & hygiene per SIPL/PDS/002 requires pre-employment and periodic medical examination of production operators (a medical officer has been appointed and examinations are being completed before the audit), illness/lesion reporting, and hygiene rules (no jewellery, food, drink or smoking in production). Entry/exit and gowning per SIPL/PDS/001 mandates factory clothing and hair covering in foil-contact areas, with stricter gowning applying to the ISO 8 printing cleanroom on qualification.

9.0 PREMISES, INFRASTRUCTURE AND CONTAMINATION CONTROL

Premises provide segregated, flow-logical areas for warehousing, foil mill, conversion, printing, slitting/packing, QC laboratories and utilities (plant layout and man–material flow annexed to the SMF). Contamination control strategy elements: physical segregation of processes; polyethylene wrapping of released coils; status labelling; cleaning & sanitisation per SIPL/QAS/021; pest control via licensed contractor per SIPL/QAS/016; solvent exhaust/abatement and dust extraction; environment monitoring of warehouse and process areas per SIPL/WHS/006; ISO 8 cleanroom (2×22 TR DX, 27,000 CFM AHU, H14 HEPA, 18–24 °C, RH 45–60 %) commissioning for the printing area by 20 July 2026 with qualification per the VMP; and waste segregation per SIPL/QAS/015. Utilities affecting quality (oil-free compressed air 500 CFM, thermic fluid 10 lakh kCal/hr, chilled water, RO water, 500 kVA DG) are controlled and monitored as described in the SMF §4 and VMP §8.

10.0 EQUIPMENT, CALIBRATION AND MAINTENANCE

Production and laboratory equipment is uniquely identified per SIPL/QAS/012, operated per equipment SOPs (SIPL/PDI, QCI, ENI series), maintained per SIPL/ENS/002 with authorisation of maintenance work per SIPL/ENS/001 (daily, weekly and scheduled preventive maintenance with checklists SIPL/MECH/REC/01–03 and breakdown Why-Why/CAPA per SIPL/MECH/REC/04), and calibrated per SIPL/QAS/006 (external NABL-traceable calibration of QC/measuring instruments at annual frequency with a controlled due-date list). Qualification status and strategy (new-equipment DQ/IQ/OQ/PQ dossiers; retrospective qualification of legacy machines) is governed by SIPL/QAS/009 and the VMP. Equipment not in a calibrated/qualified state is status-labelled and excluded from GMP use.

11.0 SUPPLIER QUALIFICATION AND PURCHASING CONTROLS

Vendors of product-contact and process materials (foil stock, lacquers/VMCH, inks, adhesives, solvents, PE, cores, packing materials) and key service providers (external NABL-accredited labs, calibration agencies, pest control, transport) are qualified per SIPL/QAS/007: classification (Class I product-contact/process; Class II packing), Vendor Assessment Questionnaire (SIPLQAS-007F0100), regulatory declarations (TSE/BSE per EMA/410/01; food-contact/food-grade including FDA 21 CFR 175.300 where applicable; nitrosamine; origin of material), COA review, sample approval, and risk-based vendor audits (H2-2026 plan: 26 vendors, Class I critical/high front-loaded, commencing 13 July 2026). Until the qualification programme is complete, incoming inspection and COA review serve as the interim control over supplier-related quality risk. External testing and calibration laboratories are NABL-accredited; formal quality/technical agreements with them are not yet in place and are a planned improvement.

12.0 MATERIAL MANAGEMENT

Receipt per SIPL/WHS/001 (verification against PO, vendor tag/COA, damage check, GRN, quarantine labelling); sampling and testing of RM/PM per SIPL/QCS/002 and /004; QC disposition with status labels (Quarantine/Under Test/Approved/Rejected); storage per SIPL/WHS/002 (palletised, off-floor, FIFO, protected from dust/moisture, temperature/RH monitored per SIPL/WHS/006); issuance to production and returns per SIPL/WHS/003; physical inventory verification per SIPL/WHS/007; rejected/expired material segregation and disposal per SIPL/WHS/008; label stock control per SIPL/QAS/014.

13.0 PRODUCTION AND IN-PROCESS CONTROLS

Production is planned per SIPL/PDS/003 and executed against batch records with product start-up per SIPL/PDS/004 and stage SOPs (SIPL/PDI/001–011). Eleven in-process inspection points (QAP) from incoming foil stock to dispatch control gauge/width, GSM, surface and edge quality, pinholes, wettability, coating GSM, adhesion, heat-seal, bond strength, shade/first-off, registration and reel identification, executed by production and QC per SIPL/QCS/003. In-house lacquer/wash preparation is controlled per SIPL/PDS/005 (shellac) and /006 (VMCH) with viscosity verification. Cross-contamination, line clearance and mix-up control per SIPL/PDS/007: one product/artwork per line, documented line clearance at start-up and changeover, removal of previous product/cylinders/inks/labels, machine and material status labelling. Batch numbering, release and expiry determination per SIPL/QAS/013; product codes per SIPL/QAS/011.

14.0 PRINTED PACKAGING MATERIAL CONTROLS, TRACEABILITY AND RECONCILIATION

Printed foil receives the enhanced controls expected by ISO 15378 for printed materials: customer artwork approval and controlled artwork/shade-card masters per SIPL/QAS/008; gravure cylinder identification, storage and certified destruction on obsolescence per SIPL/QAS/008; first-off/proofreading approval against approved artwork before run continuation; on-line registration/camera monitoring with periodic camera challenge; segregation of different artworks; batch-wise reconciliation of printed output vs. input with accounting of samples and scrap; and defacing/controlled destruction of printed scrap per SIPL/QAS/015 to prevent misuse of customer-branded material. Traceability is maintained from vendor mother-coil number through stage-wise reel tags (reel number, size, specification, weight) to finished-goods labels, COA and dispatch documents, enabling 24-hour trace in support of customer recalls. The gravure printing line is not yet in commercial operation; accordingly, printed-material reconciliation and camera-challenge records are not yet available, and the site will operate these controls per the approved SOPs (verified by the Quality department) once printing commences, with reconciliation tolerance limits ratified by QA at that time.

15.0 QUALITY CONTROL, OOS AND BATCH RELEASE

QC operates independent laboratories (QC, Process, Conversion) testing against approved specifications and 26 Standard Test Methods (SIPL/STM/001–026) with sampling per SIPL/QCS/004. Instruments are calibrated externally with controlled due dates; reagents/solutions/standards per SIPL/QAS/032. Out-of-specification results follow SIPL/QCS/007 with laboratory and, where required, manufacturing investigation, retest rules and CAPA linkage. Final inspection per SIPL/QCS/006; batch review, release and COA issuance per SIPL/QCS/005; QA release for dispatch with pre-dispatch inspection per SIPL/QAS/020. Tests beyond in-house scope are subcontracted to qualified external laboratories under QA oversight.

16.0 VALIDATION AND QUALIFICATION GOVERNANCE

Validation governance is defined by SIPL/QAS/009 and executed under the Validation Master Plan SIPL/VMP/001: risk-based DQ/IQ/OQ/PQ for new equipment; retrospective qualification for legacy revamped equipment; process validation of coating, lamination and printing (three lots; revalidation every two years and after major change); cleaning verification at changeovers; test-method suitability verification; utility qualification (ISO 8 cleanroom to ISO 14644, compressed air to ISO 8573-1, monitored RO water); and computerised-system controls. QA approves all protocols and reports and maintains the validation matrix; the validated state is preserved through change control, calibration, PM and periodic review.

17.0 PQS ELEMENTS: MONITORING, CAPA, CHANGE MANAGEMENT, RISK AND KNOWLEDGE MANAGEMENT

ICH Q10 element SIPL implementation

Process performance & In-process results at 11 inspection points, QC product quality trend review, water/environment monitoring, monitoring complaint and rejection trending; consolidated annually in the PQR (SIPL/QAS/029)

CAPA system Incidents/deviations per SIPL/QAS/004; failure investigation & CAPA per SIPL/QAS/031 (root-cause tools incl. Why-Why analysis), effectiveness checks, logs reviewed at management review

Change management SIPL/QAS/002: classification, impact assessment (quality, validation, regulatory/customer notification), approval before implementation, post-implementation review; supplier/material changes linked to SIPL/QAS/007

Management review of SIPL/QAS/019 — inputs: objectives, audits, the PQS complaints, deviations/CAPA, changes, training, resources, validation status; outputs: decisions and resourced actions

Quality risk SIPL/QAS/025 (risk & opportunity of interested management parties), SIPL/QAS/028 (HIRA), product/process risk assessments (mix-up per SIPL/PDS/007; nitrosamine risk assessment; food-contact/migration compliance file) — risk outputs feed validation, vendor and audit programmes

Knowledge management Controlled specifications, STMs, validated parameters, PQR trends, complaint learnings and OEM documentation retained and used in change evaluation and training

18.0 COMPLAINTS, RETURNS, RECALL AND CUSTOMER NOTIFICATION

Customer complaints per SIPL/QAS/005: logging, batch-record/retention-sample investigation, customer response with CAPA, and trending; customer feedback per SIPL/SAS/002. Returned goods per SIPL/WHS/008: quarantine, assessment and QA disposition. Recall support per SIPL/QAS/010: batch traceability to consignments, customer and (where applicable) authority notification support, retrieval coordination and effectiveness verification; a mock recall exercise validating the traceability chain is performed. Customers are proactively notified of significant changes affecting their products per SIPL/QAS/002 and customer quality agreements.

19.0 INTERNAL AUDIT AND SELF-INSPECTION

Internal audits per SIPL/QAS/018 cover all QMS areas (QA, QC, Production, Warehouse, Engineering and data-integrity practices), performed by trained auditors independent of the audited area, with graded findings, CAPA and follow-up verification. The internal audit programme is scheduled on a quarterly basis commencing August 2026; no internal audit has been conducted prior to this date, the site being newly established under the current quality system. Audit results are a standing management-review input.

20.0 MANAGEMENT REVIEW AND CONTINUAL IMPROVEMENT

Management review per SIPL/QAS/019 operates on a defined cadence: weekly by video call, monthly in person at the plant, and quarterly following the internal audit. Management reviews have been held by video call and in-person meetings in the past; the formal, minuted Management Review Meeting (MRM) programme under SIPL/QAS/019 commences 15 July 2026. Standing inputs include quality objectives, complaints, deviations/CAPA, audit results, changes, training and validation status; outputs are resourced decisions and improvement actions. Continual improvement is driven through CAPA effectiveness, objective trends, PQR recommendations, audit findings, customer feedback and the plant revamp/investment programme (new converting equipment, ISO 8 cleanroom, expanded SOP and validation framework).

21.0 RECORD RETENTION AND ARCHIVAL

Quality records (batch records, test records, COAs, calibration, training, complaints, audits, validation) are retained for a minimum of 5 years, protected from loss and deterioration and retrievable within 24 hours for traceability. Archival responsibility rests with the Quality Assurance team, in the QA department office, with disposal only on QA authorisation.

22.0 CUSTOMER-SPECIFIC QUALITY REQUIREMENTS

Customer-specific requirements (specifications, artwork standards, additional testing, notification and audit rights) are captured at order review per SIPL/SAS/001, translated into specifications and batch documentation, and honoured through quality agreements. As this is the site's first customer audit, there are at present no customer quality agreements in force and no separate register of customer-specific requirements is maintained; customer requirements received at order review (SIPL/SAS/001) are translated directly into specifications and batch documentation. As customer quality agreements are established, a register will be maintained by QA/Commercial. For printed-foil customers, artwork and printing-specific commitments will be operationalised once the printing line is commercial, per the approved SOPs verified by the Quality department.

23.0 REFERENCES AND SOP CROSS-REFERENCE

This manual is implemented through the 111 SOPs in the Master Index (SIPL/QAS/001/F05): Production SIPL/PDI/001–011, SIPL/PDS/001–007; QC SIPL/QCS/001–007, SIPL/QCI/001–009; QA SIPL/QAS/001–032; Test methods SIPL/STM/001–026; Warehouse SIPL/WHS/001–010; Sales SIPL/SAS/001–002; Purchase SIPL/PUS/001; Engineering SIPL/ENI/001–003, SIPL/ENS/001–002; HR SIPL/HRS/001. External references: ISO 15378:2017; ISO 9001:2015; ICH Q9/Q10; IS 15392; IS 16011; EMA/410/01, CPMP/QWP/4359/03, EMEA/CVMP/205/04 (vendor declarations); ISO 14644-1; ISO 8573-1. Related top-level documents: SIPL/SMF/001; SIPL/VMP/001.

24.0 REVISION HISTORY AND ANNEXURES

No.

00 ____________ Not New document — first issue of the applicable Quality Manual under the SIPL/QAS (first documentation framework; supersedes issue) SIPL-QM-18.

Annexures: A — Organisation Chart (SIPL/OC/001, showing Quality reporting to the Managing Director); B — Process Flow Chart (SIPL/PFC/001) with inspection points; C — Document hierarchy diagram; D — SOP Master Index; E — Quality Policy (signed); F — Interaction/process map of QMS processes.