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LIFESPARK Pharma Private Limited

Quality Assurance & Quality Control

A batch is released only when it meets its written specification. This page sets out who decides that, and on what evidence.

Twin pillars

We treat quality not as a final inspection box to tick, but as a continuous, systematic practice embedded into every stage of a product's lifecycle.

Quality Assurance (QA) and Quality Control (QC) govern our corporate operations in Mumbai and our partner manufacturing facilities — from the raw molecule to the finished package in a patient's hands.

Standards
IP · BP · USP
Stability zone
IVB
Every batch

Five gates before a pack leaves

  1. 1

    Incoming material check

    Actives and excipients are quarantined and tested against specification before release to production.

  2. 2

    In-process control

    Defined parameters are checked and recorded at each stage of manufacture, not only at the end.

  3. 3

    Finished product testing

    The batch is tested for the parameters in its specification, against the applicable pharmacopoeial monograph.

  4. 4

    Batch release

    A qualified person reviews the complete batch record and results, and either releases or rejects the batch.

    Release or reject
  5. 5

    Retention and stability

    Retention samples are held for the required period; stability samples are pulled and tested on schedule.

How they protect you

QC tests the product. QA guards the system.

Reactive · analytical

Quality Control

Tests the product itself, at every milestone.

  • Raw material assays
  • In-process batch testing
  • Finished product analysis
  • Stability chamber testing
Proactive · systemic

Quality Assurance

Designs and monitors the ecosystem the product is made in.

  • WHO-GMP facility audits
  • Batch record verification
  • Standard operating procedures
  • Validation and tech transfer
Quality Control

Analytical precision at three milestones

Our QC laboratories are run by experienced pharmaceutical scientists, and act as the gatekeeper.

  • 01

    Raw & packaging materialNo API enters the line without passing identity, purity and limit tests. Alu-Alu foils and PVC films are checked for thickness, tensile strength and pinhole leaks.

  • 02

    In-process quality controlSamples pulled at fixed intervals. Tablets: weight, thickness, hardness, friability. Gels and sprays: viscosity, uniformity, fill-weight.

  • 03

    Finished product analysisDissolution and disintegration testing, and HPLC assays confirming the exact therapeutic dosage is present.

Quality Assurance

Systemic integrity

While QC tests the product, QA designs and monitors the whole ecosystem to prevent errors before they happen.

WHO-GMP & CDSCO audits

We source from manufacturing plants that pass WHO Good Manufacturing Practices and CDSCO guidelines.

Master batch record review

Every step — from mixing-vessel temperature to line-clearance logs — is reviewed before a batch is released.

Validation protocols

Equipment, cleanroom HVAC and purified water loops are validated and calibrated on schedule.

Stability testing

Built for Zone IVB — India's hot, humid climate

Products are stored in environmental chambers, then analysed on schedule to confirm the molecules do not degrade, change colour or lose potency in transit across Indian states.

40°C ± 2°C chamber temperature
75% RH ± 5% relative humidity
Analysis points, months from manufacture
Post-market monitoring

A sample of every batch, kept

Quality management does not stop once a product leaves our central Mumbai warehouse. We store a fixed quantity of control samples from every batch in an environmentally controlled repository. If a quality issue is ever reported from the market, the matching sample can be tested immediately.

Analytical instruments Illustrative photograph.
In the laboratory

QC equipment

  • High-performance liquid chromatography (HPLC)
  • Dissolution apparatus
  • Disintegration apparatus
  • Tablet hardness tester
  • Friability tester
  • Viscometer for gels and sprays
  • Fill-weight and uniformity check station
  • Packaging material testing — thickness, tensile strength and pinhole leak
  • Environmental stability chambers
Our quality pledge

Quality is not a checkpoint; it is our core commitment.

Every capsule, injection, spray and gel that leaves our hub carries our seal of trust. We source only purest-grade APIs, partner with WHO-GMP facilities, and subject every batch to rigorous testing. When it comes to saving lives and restoring daily wellness, there is no room for compromise.