Pharmaceutical Testing in Pakistan: What Manufacturers Outsource

Manufacturers outsource the tests that need costly instruments and run only occasionally

Some analytical work is almost always outsourced, because the instrument is expensive and the demand for it is intermittent. 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 pattern is consistent. Routine identity, assay and physical testing stays in house, because the volume justifies the equipment and the turnaround demands proximity.

Cost, accreditation scope, peak workload and microbiology push testing out of house

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

Under ISO/IEC 17025 a laboratory is accredited for specific methods, not for chemistry in general. Adding a method means adding it to the scope, with the assessment and proficiency testing that follow, so a manufacturer that runs a test twice a year inherits a permanent compliance obligation for it. Inspection and certification bodies are assessed on the same logic, against different standards.

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

Microbiological testing is a different discipline from analytical chemistry, with its own facility requirements, and a manufacturer with a chemistry laboratory may have no intention of building a microbiology one. A test report shows the same separation: its scope determines what it can support.

A contract laboratory tests and reports, and it does not release the batch

A contract testing laboratory and a contract manufacturing organisation 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 who asks a laboratory to "handle" a product can drift into assuming the laboratory has taken on a role it has not. So make the appointment explicit: what is tested, against what method, and who releases the batch. Pakistan's national regulator is the Drug Regulatory Authority of Pakistan, while international procurement often turns on WHO prequalification and on inspection regimes aligned to PIC/S. Each of them expects a named party to be accountable for release.

Check a contract laboratory on six points, starting with its method scope

Six checks, roughly in order of importance:

1. Accreditation scope for the specific method. "ISO 17025 accredited" is not enough: the laboratory needs accreditation for the method and the matrix. Accreditation for one assay does not automatically cover another that runs on the same instrument.

2. Method transfer documentation. When a method moves between laboratories, the transfer is a documented exercise, with no 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 where an inspection is most likely to raise a finding.

4. Proficiency testing for the relevant methods, with the most recent round and its 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.

Then ask 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.

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

The report is the deliverable. It is audit-ready only if it carries the method, the accreditation reference and a traceable chain of custody.

For nutraceuticals and herbal products the same logic applies to identity, potency and adulteration testing. There, 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.

What Tti Labs tests for 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 for raw materials, active pharmaceutical ingredients, excipients and finished dosage forms.

• Method development and validation aligned to ICH quality guidelines and pharmacopoeial requirements, and 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: sterility, extractables and leachables, elemental impurities, container closure integrity, mechanical strength and dimensional verification.

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

Tti Labs tests samples and reports results. It does not release a batch to market or act as a contract manufacturer, and a test report is not a marketing authorisation.

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

Related guides: Food and Agricultural Export Testing in Pakistan: The Certification Route.