Pharmaceutical Testing in Pakistan: What Manufacturers Outsource

Key Takeaways

• Outsourced work clusters around capital-intensive and episodic testing: method development and validation, stability studies, elemental impurities, residual solvents and microbiological assays.

• The drivers are instrument cost, the burden of maintaining an accreditation scope for each method, and peak workload that in-house capacity cannot absorb.

• A contract testing laboratory and a contract manufacturing organisation are different appointments, and the distinction matters for liability.

• A contract laboratory must be checked on scope, not reputation: accreditation covering the specific method, not the general category.

• A test report is only audit-ready if it carries the method, the accreditation reference and a traceable chain of custody.

The test families that travel

Certain analytical workloads are almost always outsourced, because the instrument required is expensive and the demand for it is intermittent, so a manufacturer running forty batches of one product a year cannot justify a triple quadrupole mass spectrometer that sits idle most of the year.

The families that most commonly leave the site:

The pattern is consistent, and it runs in one direction: capital intensity plus intermittent demand produces outsourcing, while routine identity, assay and physical testing stays in house, because the volume justifies the equipment and the turnaround demands proximity.

Why manufacturers outsource rather than expand

Four pressures drive the decision, and they are worth understanding because they explain the workload a contract laboratory receives.

Capital and running cost. A mass spectrometry suite is a substantial investment, and its running costs continue whether or not there is work for it, so a manufacturer weighing a new instrument against an outsourced programme is usually comparing a fixed cost against a variable one.

Accreditation scope maintenance. Under ISO/IEC 17025 a laboratory is accredited for specific methods, not for chemistry in general, and adding a method means adding it to the scope, with the assessment and proficiency testing that follows. A manufacturer that runs a test twice a year inherits a permanent compliance obligation for it. The same logic governs the way inspection and certification bodies are assessed against different standards.

Peak workload. Submission deadlines compress. A manufacturer preparing simultaneous dossiers needs analytical capacity it would not carry permanently.

Capability that is genuinely separate. Microbiological testing is a different discipline from analytical chemistry, with its own facility requirements, so a manufacturer with a chemistry laboratory may have no intention of building a microbiology one. The same separation appears in a laboratory test report, where the report's scope determines what it can support.

Contract testing laboratory and contract manufacturer are different things

The two are frequently conflated. The confusion creates a liability gap.

A contract testing laboratory performs analytical work on samples the client supplies, and reports results. It does not release product to market, and it takes no responsibility for the manufacturing process.

A contract manufacturing organisation makes the product under a client's licence, and carries manufacturing responsibility for what it produces.

A supplier asking a laboratory to "handle" a product can drift into assuming the laboratory has taken on a role it has not, so the appointment should be explicit: what is tested, against what method, and who releases the batch. The regulatory context compounds the point, because Pakistan's national regulator is the Drug Regulatory Authority of Pakistan, while international procurement often turns on WHO prequalification and inspection regimes aligned to PIC/S, each of which expects a named party to be accountable for release.

What to check in a contract laboratory

Six checks, in the order they tend to matter:

1. Accreditation scope for the specific method. Not "ISO 17025 accredited", but accredited for the method and the matrix. A laboratory accredited for one assay is not automatically accredited for another that runs on the same instrument.

2. Method transfer documentation. When a method moves between laboratories, the transfer is a documented exercise, not an assumption that the two sites perform identically.

3. Data integrity arrangements. Audit trails on instruments, controlled access to the chromatography data system, and no shared logins. This is the area where an inspection is most likely to find a finding.

4. Proficiency testing participation for the relevant methods, with the most recent round and outcome available on request.

5. Sample chain of custody, from receipt through storage to disposal, with the storage condition recorded.

6. Audit rights, written into the agreement, and the willingness to exercise them.

A question worth asking directly: which specific methods on your scope cover the work being sent? A laboratory that cannot answer from its own scope document is answering from memory.

What a usable test report contains

The report is the deliverable. An incomplete one cannot support a submission.

For nutraceuticals and herbal products the same logic applies to identity, potency and adulteration testing, where label-claim verification and contaminant screening carry the commercial risk, and heavy metal and pesticide residue testing sits in that group. Adulteration screening is where a supplier's reputation is most often exposed.

How TTI supports pharmaceutical and nutraceutical manufacturers

• Testing under ISO/IEC 17025 accreditation through PNAC LAB-022, with a published accreditation scope that can be checked method by method.

• Pharmaceutical analytical services spanning raw materials, active pharmaceutical ingredients, excipients and finished dosage forms.

• Method development and validation aligned to ICH quality guidelines and pharmacopoeial requirements, with stability and shelf-life studies run on ICH principles.

• Instrumentation spanning HPLC with UV, DAD and MS/MS detection, LC-MS/MS, single and triple quadrupole systems, GC-FID, GC-MS and headspace GC-MS, AAS, ICP-OES, ICP-MS, UV/Vis, FTIR and ELISA.

• Microbiological testing in a US IAC certified microbiology laboratory with ISO Class 5 and Class 7 environments, including Bacterial Endotoxin (LAL) and bioburden testing.

• Surgical instrument and medical device testing covering sterility, extractables and leachables, elemental impurities, container closure integrity, mechanical strength and dimensional verification.

• Nutraceutical and herbal testing covering vitamin and mineral estimation, fatty acid profiling, nutritional profiling, heavy metals, pesticide residues, herbal extract analysis and adulteration screening.

One boundary, stated once. TTI tests samples and reports results. It does not release a batch to market, it does not act as a contract manufacturer, and a test report is not a marketing authorisation.

FAQ

Why do pharmaceutical manufacturers outsource testing at all?

Because the requirement is capital-intensive and intermittent: a mass spectrometer or a stability chamber programme carries fixed cost and continuous compliance obligations, while demand for a specific test may arrive only a few times a year.

Is a contract testing laboratory the same as a contract manufacturer?

No. A contract testing laboratory analyses samples and reports results. A contract manufacturer makes product and carries manufacturing responsibility. Conflating them creates a gap in who releases the batch.

What should a buyer check first in a contract laboratory?

The accreditation scope for the specific method and matrix, not the general claim of being accredited, because ISO/IEC 17025 accreditation attaches to methods, so a laboratory accredited for one assay is not automatically covered for another.

What makes a test report audit-ready?

A specific method reference with its version, an accreditation statement with the certificate reference, and results with limits and a pass or fail verdict. Also measurement uncertainty where relevant, sample identification, an authorised signatory and a coherent date sequence.

Does a laboratory test release a batch?

No. The manufacturer releases the batch. Testing produces evidence that supports the release decision, and the release decision remains with the licence holder.

What is the most common inspection vulnerability?

Data integrity. Instrument audit trails, controlled access to the chromatography data system and individual logins are where findings concentrate. A laboratory that cannot demonstrate these has a credibility problem independent of its results.

Conclusion

• Outsourcing is selective, clustering around capital-intensive and episodic testing rather than routine work.

• The drivers are instrument cost, per-method accreditation burden, peak workload and genuinely separate disciplines such as microbiology.

• A contract testing laboratory and a contract manufacturer are different appointments, and the difference decides who releases the batch.

• Accreditation must be checked at method level, because ISO/IEC 17025 scope attaches to methods rather than to laboratories.

• A report without a method version and an accreditation reference cannot support a regulatory submission.

Discuss pharmaceutical testing with TTI or contact the laboratory. UAN 111 786 001. ISO/IEC 17025 accredited through PNAC, LAB-022. US IAC certified microbiology laboratory.

References

1. Pharmaceutical testing services, TTI Testing Laboratories, https://ttilabs.net/pharma

2. Accreditation scope LAB-022 (ISO/IEC 17025:2017, first granted 13 May 2006, valid to 8 August 2027), Pakistan National Accreditation Council, https://pnac.gov.pk/pdfFiles/LAB-022

3. Contact, TTI Testing Laboratories, https://ttilabs.net/contact

4. ICH quality guidelines, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, https://www.ich.org/page/quality-guidelines

5. Drug Regulatory Authority of Pakistan, https://www.dra.gov.pk/

6. WHO Prequalification of Medical Products, World Health Organization, https://www.who.int/teams/regulation-prequalification

7. Pharmaceutical Inspection Co-operation Scheme, https://picscheme.org/

8. Chapter 3 Vision, Values and Accreditations and Chapter 11 Analytical Infrastructure (US IAC certified microbiology laboratory with ISO Class 5 and Class 7 environments; LC-MS/MS and GC-MS/MS added 2025; ICP-OES and ICP-MS; method development and validation; stability studies; surgical instrument and medical device testing), TTI Global Reference Publication, June 2026, Authoritative Edition, TTI Testing Laboratories. The publication is an internal TTI document with no public URL.