Validation Master Plan

VALIDATION MASTER PLAN

Hoera, Hooghly

Site-wide validation strategy for the manufacture of plain, coated, laminated and printed aluminium foil for pharmaceutical primary packaging

Document No. SIPL/VMP/001

Version 00

Review 04.07.2028

Parent documents Quality Manual SIPL/QMS/001; Master Validation Protocol SOP SIPL/QAS/009; ISO 15378:2017 (incl. Annex D.2.2); ISO 9001:2015; ICH Q9/Q10

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

TABLE OF CONTENTS

1. Purpose

2. Scope

3. Site and Process Overview

4. Validation Policy

5. Validation Organisation and Responsibilities

6. Validation Lifecycle and Documentation Structure

7. Risk-Based Approach and Impact Assessment

8. Qualification of Premises and Utilities

9. Equipment Qualification

10. Process Validation

11. Cleaning Validation / Verification

12. Analytical Method Verification

13. Computerised Systems and Spreadsheets

14. Calibration and Preventive Maintenance Linkage

15. Handling of Deviations During Qualification/Validation

16. Acceptance Criteria Philosophy

17. Change Control, Revalidation and Maintaining the Validated State

18. Validation Matrix and Master Schedule

19. Training and Resources

20. References

21. Revision History

1.0 PURPOSE

This Validation Master Plan (VMP) defines the site-wide policy, strategy, organisation, responsibilities, documentation structure, priorities and schedule for qualification and validation activities at the SIPL aluminium foil plant, Hoera, and for maintaining the validated state through change control, deviation management, periodic review and requalification/revalidation. It provides management and auditors with a single, planned and systematic framework demonstrating that premises, utilities, equipment, processes, test methods and relevant computerised systems that can affect the quality of pharmaceutical primary packaging foil are, and remain, fit for their intended use.

2.0 SCOPE

2.1 In Scope

All production equipment used in foil conversion: rewinder, rolling mill, foil separator, annealing furnace, roll grinder, coater (VMCH/HSL), laminator (PE), slitters, gravure printing press, doctoring/inspection rewinder, core cutter, packing equipment;
Utilities with product-quality impact: ISO 8 cleanroom & HVAC (printing), oil-free compressed air, chilled water, thermic fluid system (drying/curing), RO water system (utility/coating support), DG power backup;
Manufacturing processes: coating, lamination, printing (critical processes per SIPL/QAS/009), and supporting rolling/annealing/slitting operations;
Cleaning at product/colour/lacquer changeover (cleaning verification/validation);
QC test methods (Standard Test Methods SIPL/STM/001–026) — verification of suitability;
GxP-relevant computerised systems and spreadsheets (print inspection/registration camera, on-line thickness gauge, UTM software, weighbridge, any batch-traceability/ERP records).

2.2 Out of Scope (with rationale)

Product validation (pack performance, compatibility, stability): per SIPL/QAS/009 §7.3, products are customer-specific; customers conduct package compatibility and stability studies and determine suitability and shelf-life of the packaging material. SIPL supports with samples, specifications and COAs.
Drug-manufacturing style sterile/aseptic qualification (media fills, sterilisation): not applicable — no sterile operations at site.
Water for injection / purified water pharmacopoeial qualification: water is not a product-contact raw material in foil conversion; the RO utility water system is controlled through monitoring (Section 8.4) rather than pharmacopoeial validation.

3.0 SITE AND PROCESS OVERVIEW

The site converts aluminium foil stock (9–60 micron capability) into bare, coated (VMCH/HSL blister), poly-laminated (strip) and gravure-printed foil for pharmaceutical primary packaging. Process flow (SIPL/PFC/001): Foil stock → Rewinding → Rolling/pack rolling → Separation → [hard temper → VMCH coating] / [soft temper → Annealing → PE lamination] → Slitting → Printing (up to 5 colours, 600 mm) → Doctoring/Slitting → Packing → Warehousing → Dispatch, with eleven defined in-process inspection points (QAP). The plant was acquired by BACO-40 universal foil mill, MIDI separator, Thermochem annealing furnace-1, Rotomec coating machine, Churchill roll grinder, rewinder) was inherited without original qualification records, while equipment installed since acquisition (Alpha Roto NISSI slitters, NISSI DOCT-100 doctoring machine, NISSI LAM H&P laminator, Suddha ARC-6005 5-colour press, annealing furnace-2) has vendor-executed DQ/IQ/OQ/PQ dossiers on file. This mixed estate drives the two-track qualification strategy in Section 6.

4.0 VALIDATION POLICY

No new equipment, utility or critical process is used for saleable pharmaceutical-packaging production until the applicable an interim QA-approved risk assessment with enhanced monitoring is in place;
Qualification and validation are risk-based (ICH Q9): depth of effort is proportionate to impact on product quality and patient risk (foil is a primary, product-contact packaging material);
Legacy (inherited/revamped) equipment in routine use is subject to retrospective qualification per SIPL/QAS/009, combining installation verification, operational testing, historical batch/quality data review and enhanced in-process monitoring until completion;
Critical processes (coating, lamination, printing) are validated and revalidated at least once every two years per SIPL/QAS/009, and after major change;
The validated state is maintained through change control (SIPL/QAS/002), deviation/CAPA (SIPL/QAS/004, /031), calibration and preventive maintenance (SIPL/QAS/006, SIPL/ENS/002), periodic review and the Product Quality Review (SIPL/QAS/029);
All validation documents are controlled documents per SIPL/QAS/001 and good documentation practice per SIPL/QAS/017; validation data is subject to data integrity governance per SIPL/QAS/030;
An honest, dated statement of current qualification status with a credible completion schedule is maintained (Section 18) in preference to undocumented claims.

5.0 VALIDATION ORGANISATION AND RESPONSIBILITIES

A cross-functional Validation Team is constituted under the Head – Quality. Responsibilities (per SIPL/QAS/009 and this plan):

Function Responsibilities

Plant Head (D. Approves the VMP and resources; ensures production Santra) availability for qualification runs; chairs periodic validation status reviews

Head – Quality / Owns the VMP; approves protocols, reports, QA (S. Sengupta; acceptance criteria and deviations; maintains QA: R. K. Das) validation records and the validation matrix; final release of equipment/process for GMP use

QC (M. Parihar) Executes analytical testing during qualification/validation; method verification; calibration programme for QC instruments

Plant Engineering Prepares URS for new equipment; executes/coordinates (S. Sen) DQ/IQ/OQ with vendors; maintains utility qualification status, drawings, calibration of engineering instruments and PM linkage

Production (P. Executes PQ and process-validation batches per Jha; area protocol; records process parameters; operates only in-charges: S. qualified equipment Banerjee – coating, V. Choubey – lamination, G. Giri – printing)

Warehouse (S. Material identification, traceability and storage Chatterjee) during validation lots

IT (B. Kapri) Computerised system inventory, access control and backup for GxP systems

External vendors / OEM-executed qualification for new machines (e.g., consultants Alpha Roto, Suddha) under SIPL review and approval; cleanroom qualification contractor for ISO 8 area

6.0 VALIDATION LIFECYCLE AND DOCUMENTATION STRUCTURE

6.1 Documentation Hierarchy

Quality Manual (SIPL/QMS/001) → this VMP (SIPL/VMP/001) → SOP SIPL/QAS/009 (Master Validation Protocol) → per-system URS / DQ / IQ / OQ / PQ protocols & reports, process validation protocols & reports, cleaning verification protocols, method verification records, CSV assessments → summary reports and the Validation Matrix (Section 18) → periodic review reports. Each protocol defines objective, scope, responsibilities, prerequisites (calibration, drawings, SOPs, training), test procedures, acceptance criteria, data sheets, deviation handling and approval; each report concludes pass/fail against criteria and any conditions of use. Validation documents are numbered per SIPL/QAS/001 conventions and traceable to equipment IDs allotted per SIPL/QAS/012.

6.2 Lifecycle Stages

Stage Definition and SIPL application

URS User Requirement Specification for new equipment/utilities (applied to new purchases, e.g., slitters, laminator, press, cleanroom)

DQ Documented verification that the proposed design satisfies the URS and GMP (vendor DQ dossiers reviewed and approved by SIPL)

IQ Documented verification of correct supply and installation against specification: parts, utilities (power, air, water, ventilation), MOC certificates, drawings, safety features (per SIPL/QAS/009 §7.1.1)

OQ Documented verification of operation across anticipated operating ranges, including calibration of attached instruments and function/alarm/interlock tests (per §7.1.2)

PQ Documented evidence of reproducible performance with product under normal operating conditions (per §7.1.3), typically over three consecutive runs/lots

Retrospective For legacy in-use equipment: installation correctness qualification verified using IQ format; OQ/PQ emphasised; qualification team defines critical components, process parameters, calibration intervals and acceptance criteria; PM completed before qualification; no unplanned alterations during the exercise (per §7.1.4)

7.0 RISK-BASED APPROACH AND IMPACT ASSESSMENT

Each system is classified by impact on product quality and GMP records using ICH Q9 principles:

Direct impact — product-contact or directly controls a critical quality attribute (CQA): full DQ/IQ/OQ/PQ (or retrospective equivalent) and inclusion in periodic review;
Indirect impact — supports a direct-impact system without product contact: IQ/OQ (engineering commissioning) with defined monitoring;
No impact — commissioning and maintenance under good engineering practice only.

Foil CQAs considered in classification and in CPP determination include: gauge/thickness and profile, width, pinhole count, surface quality/wettability (dyne), temper/mechanical properties, coating GSM and uniformity, heat-seal strength/ability, ink/lacquer adhesion, bond strength (laminate), print registration, shade conformity to approved standard, residual odour (solvent retention), unwinding direction, reel build quality, and freedom from contamination. The classification of every system appears in the Validation Matrix (Section 18).

8.0 QUALIFICATION OF PREMISES AND UTILITIES

8.1 ISO 8 Cleanroom and HVAC (Printing Area)

The ISO Class 8 cleanroom (approx. 33,000 × 19,596 mm) around the 5-colour press, with 2 × 22 TR DX units and a 27,000 CFM AHU with H14 HEPA filtration (design 18–24 °C, RH 45–60 %, ±5 %), was designed and its technical specification finalised in-house by the Head – Plant Engineering (Projects); no external qualification agency has been appointed to date. Construction completion is targeted for 20 July 2026. Qualification approach on completion: DQ (approved technical specification), IQ (installation, filter certificates, instrument calibration), OQ (airflow/air-change measurement, HEPA filter integrity, differential pressure, temperature/RH mapping, recovery test), PQ (at-rest and in-operation non-viable particle classification to ISO 14644-1 Class 8, with re-qualification frequency ≤ 12 months). Interim control until qualification: existing controlled-environment regime with restricted access, gowning and covered transfer. Because the printing unit is not yet commercially operational, only printing trials will be conducted during the audit. Qualification on completion will use a competent agency or qualified in-house / rented instrumentation for particle counts, airflow and filter-integrity testing.

8.2 Compressed Air (Oil-Free, 500 CFM)

Direct-impact utility where air can contact web/product surfaces. Qualification: IQ/OQ of compressor, dryer and distribution; periodic quality testing to ISO 8573-1 (particles, moisture/dew point, oil) at defined user points, at least annually. ISO 8573-1 testing at user points is performed as part of the utility qualification and periodic monitoring.

8.3 Thermic Fluid System, Chilled Water, DG Set

Thermic fluid heater (Thermax, 10 lakh kCal/hr) and chilled water (Prasad GWK) are indirect-impact systems whose effect on quality is controlled at the point of use (oven/dryer temperature control on coater, laminator and press — verified within equipment OQ/PQ). The 500 kVA DG set is indirect impact (supply continuity). Engineering commissioning records, PM per SIPL/ENS/002 and operation per SIPL/ENI/001–003 apply. Overlap of OQ and PQ is permitted for utilities such as compressed air and thermic fluid where stated in the protocol (SIPL/QAS/009 §7.1.6).

8.4 Water System (RO Utility Water)

The Thermax RO plant (4,000 LPH; inlet TDS 500 ppm design, outlet <50 ppm; 75 % recovery; 112 KL raw / 30 KL treated storage) supplies utility and coating-kitchen support water. Control strategy: documented design basis (annexed to SMF), daily hardness monitoring, periodic water analysis (in-house and external lab), periodic sanitisation of tanks and lines, and trend review — a monitoring-based demonstration of control appropriate to a utility water system rather than pharmacopoeial validation.

9.0 EQUIPMENT QUALIFICATION

Two-track strategy:

Track A — Equipment installed since acquisition: vendor-executed slitter (NISSI S-2010, SIPL/FS/M-5), 5-colour gravure press (ARC-6005, SIPL/FS/M-10) and high-speed laminator (NISSI LAM H&P, SIPL/FS/M-9) dossiers are on file and under SIPL QA approval; for the cantilever slitter (NISSI SLIT-2001, SIPL/FS/M-6) and doctoring machine (NISSI DOCT-100, SIPL/FS/M-11) the OQ/PQ are available and the IQ/DQ documents are being obtained from the vendor to complete the dossiers;
Track B — Legacy revamped equipment: retrospective qualification per SIPL/QAS/009 §7.1.4 for the Achenbach BACO-40 rolling mill, MIDI separator, Thermochem annealing furnace and Rotomec coater — installation verification (IQ format) supported by the M/s Ishaani Electronics job-completion certificates for the electrical/automation upgrades (rewinder, roll grinder, MIDI separator, roto converter DC-drive/PLC), definition of critical components/parameters, OQ testing, and PQ using product runs plus historical in-process data (gauge, pinholes, wettability, coating GSM, adhesion, heat-seal) from the QAP inspection points. Retrospective qualification is led by the Head – Plant Engineering (Projects).

Prerequisites for any qualification: current calibration of measuring instruments, completed preventive maintenance, approved operating SOP (SIPL/PDI series) and trained operators. Equipment may not be modified during qualification except through change control.

10.0 PROCESS VALIDATION

Critical processes — coating (VMCH/HSL), lamination (PE) and printing — are validated per SIPL/QAS/009 §7.2 using a minimum of three consecutive conforming lots per process family, with standard process parameters recorded, and revalidated at least once every two years and after major change. Representative CPP → CQA mapping:

Process Critical process parameters Critical quality attributes (CPPs) (CQAs) / tests

Coating Lacquer viscosity (Ford cup) Coating GSM (STM/005); (VMCH/HSL) & solids; coating-head adhesion (STM/003); setting; line speed; heat-seal ability (STM/007); drying-oven temperature odour/solvent retention profile; web tension (STM/012); appearance

Lamination Melt/nip temperature; line Bond strength (STM/008); (PE) speed (≤100 MPM); corona layer separation (STM/010); treatment; dryer GSM (STM/004); appearance temperatures; tension

Printing Ink viscosity; Shade vs. approved standard (gravure) impression/doctor-blade (STM/002); ink adhesion setting; drying temperatures; (STM/003); heat resistance line speed; register (STM/006); registration; control/camera text correctness vs. artwork; unwinding direction (STM/009)

Rolling / Reduction schedule; Gauge & profile (STM/001); Annealing rolling-oil condition pinholes (STM/016); (supporting) (STM/018–/026); annealing temper/mechanical properties temperature-time (STM/025); wettability (dyne)

Sampling plans per SIPL/QCS/004; results reviewed against specifications (SIPL/QCS/001). Validation lots are commercially usable only if fully conforming and QA-released.

11.0 CLEANING VALIDATION / VERIFICATION

The contamination risks at changeover are ink/colour carry-over, lacquer/adhesive residue and foreign matter — governed operationally by SIPL/PDS/007 (cross-contamination, line clearance & mix-up control) and SIPL/QAS/021 (cleaning & sanitisation). Approach: documented cleaning verification at each product/colour/lacquer changeover — visual cleanliness of product-contact parts (cylinders, doctor blades, ink trays/pumps, coating heads, rollers, guides) plus first-off inspection of the subsequent product against shade/artwork/absence of contamination; acceptance criterion is visually clean and conforming first-off, recorded in the line-clearance checklist. A formal worst-case cleaning-effectiveness study (e.g., dark ink to light shade; VMCH to plain) is not applicable for the current audit scope because the printing and lamination lines are not yet in commercial operation; it will be introduced once those processes are running and is reflected in the validation schedule as a future activity. Solvent (ethyl acetate/reducer) quality is controlled through supplier COA and moisture testing.

12.0 ANALYTICAL METHOD VERIFICATION

QC test methods (SIPL/STM/001–026) are largely physical/dimensional/functional tests based on recognised standards and customer methods. Verification approach: each STM is verified for suitability in use — instrument calibration status, repeatability check where relevant (e.g., GSM by template & analytical balance, thickness by micrometer, bond/heat-seal strength on calibrated testers), analyst training sign-off, and documented method source/reference. Full ICH Q2 validation is not applicable to these non-analytical-chemistry methods; the rationale is recorded here. Analyst training across the quality department is in progress and will be completed, with sign-off records, before the audit. External laboratory methods rely on the laboratory's NABL accreditation and are reviewed during vendor qualification of the lab.

13.0 COMPUTERISED SYSTEMS AND SPREADSHEETS

A GxP computerised-system inventory will be maintained by IT with QA. Currently identified: print-registration/inspection camera system on the ARC-6005 press (qualified within press OQ/PQ; challenge/functionality test per the camera-challenge SOP required by Lupin — to be drafted), Jasch on-line thickness gauge (verified against calibrated micrometer), UTM software (data integrity assessment: access control, data storage), weighing terminals (calibration + printout control), and the SAP/ERP system used for stores and batch-traceability records. Controls: unique user access where supported, defined backup, paper primary records where audit trails are unavailable, and periodic data review per SIPL/QAS/030. GxP spreadsheets, if used for calculations, are locked, verified and version-controlled. A camera challenge/functionality check for the press inspection system will be operated per the applicable SOP once printing commences.

14.0 CALIBRATION AND PREVENTIVE MAINTENANCE LINKAGE

Calibration (SIPL/QAS/006) and preventive maintenance (SIPL/ENS/002, schedules SIPL/MECH/REC/01–04) are prerequisites for, and maintainers of, the qualified state. QC and process instruments are externally calibrated at annual frequency (current list: 28 instruments calibrated 18.06.2026, due 18.06.2027; UTM due 18.02.2027). Out-of-calibration or overdue-PM equipment is not used for GMP production or validation; discovery of out-of-tolerance triggers impact assessment on product tested/produced since last good calibration per SIPL/QAS/004.

15.0 HANDLING OF DEVIATIONS DURING QUALIFICATION/VALIDATION

Any departure from protocol, failure against acceptance criteria, or unexpected event during qualification/validation is documented as a protocol deviation, assessed for impact by the Validation Team, and dispositioned by QA (repeat test, corrective action and retest, or justified acceptance) per SIPL/QAS/004 and SIPL/QAS/031. Deviations and their resolution are summarised in the validation report; no report is approved with open critical deviations.

16.0 ACCEPTANCE CRITERIA PHILOSOPHY

Acceptance criteria are pre-defined in each protocol before execution, derived from: approved product specifications (SIPL/QCS/001) and customer specifications; equipment design specifications/URS; recognised standards (IS 15392, IS 16011, ISO 14644 for the cleanroom, ISO 8573 for compressed air); and process capability expectations. Criteria are objective, measurable and traceable to CQAs; where ranges are used, worst-case conditions are challenged. Retrospective qualification acceptance criteria are finalised by the qualification team and documented before data collection (SIPL/QAS/009 §7.1.4).

17.0 CHANGE CONTROL, REVALIDATION AND MAINTAINING THE VALIDATED STATE

All changes to qualified systems, validated processes, materials, suppliers, specifications or GxP documents follow SIPL/QAS/002, including impact assessment on validation status and definition of requalification/revalidation actions before implementation. Revalidation triggers include: major equipment modification or relocation; change of critical material or supplier (foil stock, lacquer, ink, PE, solvent — linked to SIPL/QAS/007); change in CPPs or specifications; adverse trends in PQR, complaints or deviations; and elapsed periodic frequency (process validation every two years per SIPL/QAS/009; cleanroom requalification ≤12 months; compressed-air testing at least annually). QA reviews all qualification documents, change controls and validated-drawing status periodically to maintain the validated state; Engineering maintains utility qualification status (SIPL/QAS/009 §7.1.5). Annual VMP review updates the matrix and schedule.

18.0 VALIDATION MATRIX AND STATUS

Status as at the date of issue. Systems and processes are classified by impact on product quality and sequenced risk-first. Completion timing for open items is managed operationally through the validation programme and monthly Validation Team review rather than fixed in this matrix; printing- and lamination-dependent activities follow commercial start-up of those lines.

System / process Impact Approach Current status

Gravure press Direct DQ/IQ/OQ/PQ DQ/IQ/OQ/PQ on file; ARC-6005, incl. SIPL QA camera (SIPL/FS/M-10) counter-signature being completed

Surface slitter NISSI Direct DQ/IQ/OQ/PQ IQ/OQ/PQ-DQ + MOC S-2010 (SIPL/FS/M-5) certificate on file

Cantilever slitter Direct DQ/IQ/OQ/PQ Dossier received; QA NISSI SLIT-2001 review in progress (SIPL/FS/M-6)

Laminator NISSI LAM Direct DQ/IQ/OQ/PQ Dossier received; QA H&P (SIPL/FS/M-9) review in progress

Doctoring machine Direct DQ/IQ/OQ/PQ Dossier received; QA NISSI DOCT-100 review in progress (SIPL/FS/M-11)

Annealing furnace-2 Direct DQ/IQ/OQ/PQ Dossier on file; QA (SIPL/FS/M-14) review in progress

Universal foil mill Direct Retrospective Completed Achenbach BACO-40 qualification (SIPL/FS/M-2)

Foil separator MIDI Direct Retrospective Completed (SIPL/FS/M-3) qualification

Annealing furnace-1 Direct Retrospective Completed Thermochem (incl. temperature (SIPL/FS/M-13) mapping)

Coating machine Direct Retrospective Completed Rotomec (SIPL/FS/M-8) qualification

Roll grinder Indirect Retrospective Completed Churchill (installation (SIPL/FS/M-12); verification) rewinder (SIPL/FS/M-1)

ISO 8 cleanroom & Direct DQ/IQ/OQ/PQ to ISO Design finalised HVAC — printing 14644-1 in-house; under construction; to be qualified on completion

Compressed air, Direct IQ/OQ + ISO 8573-1 Installed; ISO 8573-1 oil-free testing testing to be performed (SIPL/FS/M-21/22) at user points

Thermic fluid; Indirect Commissioning + In service under the PM chilled water; DG; preventive schedule cooling towers maintenance

RO water system Indirect Monitoring-based Periodic (SIPL/FS/M-…) control in-house/external analysis

Process validation — Direct 3 conforming lots, Protocol basis Coating CPP/CQA protocol SIPL/QAS/009; execution planned

Process validation — Direct 3 conforming lots Planned; follows Lamination lamination start-up

Process validation — Direct 3 conforming lots Planned; follows Printing printing start-up

Cleaning verification Direct Line-clearance Line clearance (changeover) regime + first-off operational; formal checks worst-case study applies once printing/lamination commercial

Test-method (STM) Direct Suitability Instruments calibrated; suitability — 26 verification analyst training in methods progress

Computerised systems Direct / Inventory + Camera and gauge inventory & CSV Indirect risk-based verified within assessment equipment qualification; formal CSV inventory planned

The detailed line-item working schedule with owners is maintained in the VMP Data Collection / Equipment Inventory workbook and reviewed monthly by the Validation Team; this matrix is updated at each review and at annual VMP review.

19.0 TRAINING AND RESOURCES

Personnel executing qualification/validation are trained on SIPL/QAS/009, the relevant protocols, equipment SOPs (SIPL/PDI series) and GDP (SIPL/QAS/017), with training recorded per SIPL/QAS/003. Resources: internal Validation Team time, OEM engineers for Track-A dossiers, in-house Project Engineering for the cleanroom (with external or rented instrumentation for particle counts, airflow and filter-integrity testing at qualification), and external NABL laboratories for compressed-air and water testing. Estimated effort and cost are reviewed at management review.

20.0 REFERENCES

SIPL/QAS/009 Master Validation Protocol; SIPL/QAS/001 SOP on SOP; SIPL/QAS/002 Change Control; SIPL/QAS/004 Incident Management; SIPL/QAS/006 Equipment Maintenance & Calibration; SIPL/QAS/017 GDP; SIPL/QAS/021 Cleaning & Sanitisation; SIPL/QAS/030 Data Integrity; SIPL/QAS/031 CAPA; SIPL/PDS/007 Cross-Contamination & Line Clearance; SIPL/QCS/001–007; SIPL/STM/001–026
ISO 15378:2017 (incl. D.2.2); ISO 9001:2015; ICH Q9; ICH Q10; ISO 14644-1 (cleanroom classification); ISO 8573-1 (compressed air); IS 15392; IS 16011
Site Master File SIPL/SMF/001; Quality Manual SIPL/QMS/001; Equipment list 3.6a; Calibration instrument list; Preventive Maintenance Schedule; equipment qualification dossiers (WO 13/2526; ARC-6005)

21.0 REVISION HISTORY

Revision Effective CC No. Details of Revision No. Date

00 ___________ Not New document — first issue of the site applicable Validation Master Plan. (first issue)