What a GMP certificate does and does not mean

“We are GMP certified” is the first thing most Indian manufacturers say, and the first thing most brand owners accept as settling the quality question.

It does not settle it. It is a real and meaningful credential, and it answers a narrower question than people assume.

We hold these certifications, so this is written from the inside, including what ours do not tell you.

What GMP actually is

Good Manufacturing Practice is a framework of requirements covering how a product is made rather than what is in it.

It governs:

• Premises and layout, separation of areas, air handling, finishes that can be cleaned, pest control
• Equipment, suitability, cleaning, calibration, maintenance records
• Personnel, qualification, training, hygiene practices
• Documentation, standard operating procedures, batch manufacturing records, batch packaging records
• Raw material control, approved suppliers, incoming inspection, quarantine before release
• In-process controls, checks during production
• Quality control, a laboratory, testing, release procedures
• Retained samples
• Change control and deviation handling
• Complaint handling and recall procedures
• Self-inspection

The underlying principle is that quality is built into the process, not inspected into the product at the end. You cannot test your way to a good batch; you have to make it properly.

That is a genuinely important idea and GMP is a genuinely important framework. The problem is only in what people read into the certificate.

What it does tell you

That there is a system. Procedures are written, records are kept, and somebody is responsible for quality.

That the premises and equipment were found acceptable at audit.

That raw materials are controlled rather than accepted on trust.

That there is a QC function and release criteria.

That batches are traceable, which matters enormously if something goes wrong. A manufacturer who cannot trace a batch cannot recall it.

That retained samples exist, so a complaint two years from now can be investigated against the actual material.

That complaints and recalls have a defined process.

All of that is real and all of it matters. A manufacturer without GMP is one you should not use.

What it does not tell you

This is the part that matters for your decision.

1. It says nothing about which specification you chose

This is the big one.

GMP governs whether the batch was made to its specification, consistently and traceably. It does not govern how good that specification is.

A product specified with ashwagandha extract at a 10:1 ratio with no measured marker, and a product specified at 5% withanolides, can both be manufactured under perfect GMP. The certificate is identical. The products are not.

So GMP tells you the process was controlled. It does not tell you the product is good. That is set by the specification, and the specification is your decision as the brand owner.

2. It does not mean every batch is tested for everything

GMP requires testing against the specification. If heavy metals are not in your specification, GMP does not require them to be tested.

Which means “we are GMP certified” and “heavy metals are tested on every batch” are two separate questions, and you have to ask the second one separately.

3. It does not verify botanical identity unless specified

Species substitution in Indian herbal supply is documented and real, Phyllanthus species used interchangeably, Picrorhiza substituted with related material.

GMP requires raw material control against a specification. If the specification for identification is organoleptic, appearance, smell, taste, then GMP has been satisfied and the identity has not really been established.

Ask what identification method is used. TLC or HPLC fingerprinting against a reference is a different thing from “complies”.

4. It does not mean your product is licensed

Separate documents. A GMP-certified facility can only legally make what its licences cover, and your specific product needs to be on a licence.

Ask: is my product covered, and on which licence?

5. It does not mean the certificate is current, or for the right scope

Certificates expire. And they have a scope, specific dosage forms and sometimes specific product categories.

A facility certified for tablets and capsules is not thereby certified for liquids, or for sterile products, or for a fermented preparation.

Ask to see the certificate itself, and check the expiry date and the scope. Not the logo on the website.

6. It does not mean the product is efficacious

GMP is about manufacturing, not about whether the formulation does anything. A perfectly manufactured product with an underdosed active is a perfectly manufactured underdosed product.

7. It does not tell you they make it themselves

A real and underappreciated point. Some entities presenting as manufacturers are trading, with production at a third-party site.

There is nothing wrong with that if it is disclosed, but the licence, the liability and the quality system are at the actual plant, not at the office you visited.

Ask: is the licence in your name, and where is the plant? And then, ideally, visit it.

The certifications you will be shown, and what each is

Worth distinguishing, because they are often presented interchangeably.

GMP under Schedule T, the Ayurvedic, Siddha and Unani GMP requirements under the Drugs and Cosmetics Rules. This is the statutory GMP for Ayurvedic manufacturing in India and it is a legal requirement, not an optional credential.

FSSAI licence, a licence to manufacture food products including nutraceuticals. A licence, not a quality certification, though it comes with hygiene and safety obligations.

WHO-GMP, a certification issued by state licensing authorities against WHO guidance. Commonly required for export and generally regarded as a step above the baseline.

ISO 9001, a quality management systems standard. It certifies that you have a documented management system and follow it. It is not specific to pharmaceutical or food manufacturing and says nothing about product safety specifically.

ISO 22000 / FSSC 22000 / HACCP, food safety management systems. Relevant and meaningful for food supplements.

NABL accreditation, this is for laboratories, not for manufacturing. If a manufacturer cites NABL, ask whether it is their own lab that is accredited, or the external lab they use. Both are useful; they are different claims.

Organic certification, covers agricultural production and handling. It says nothing about dosage form manufacturing quality.

Halal, Kosher, dietary and religious compliance, not quality.

The honest summary: these are not a hierarchy where more logos means better. They answer different questions, and a wall of certificates can accompany a weak specification.

What to ask alongside the certificate

The questions that actually tell you about quality:

1. May I see the certificate? With its expiry date and scope.
2. Is my product covered by your licence?
3. Is the licence in your name, and where is the plant?
4. Are heavy metals tested on every batch, or periodically? Numbers, not “complies”.
5. What identification method is used for each botanical?
6. Is the active assayed, and against which marker?
7. Which tests are in-house and which are third-party? Is the external lab NABL accredited?
8. Do I get a COA with every batch, or on request?
9. How long are retained samples kept?
10. What is the procedure if a batch fails specification?
11. Have you had a recall? What happened?
12. May I visit the plant?

The last one is the most informative and the least used. A manufacturer who welcomes a visit is usually one whose plant matches their description of it. And forty minutes walking through a facility tells you more than any certificate, whether areas are actually separated, whether records are being filled in as work happens or afterwards, whether the QC lab is in use or decorative.

And question 11 is worth asking without embarrassment. A manufacturer who has handled a recall properly has demonstrated their system works. One who claims never to have had a single quality issue in twenty years is either very lucky or not telling you about it.

Where the real quality decisions sit

This is the point of the article.

GMP is the floor, not the ceiling. It tells you the manufacturer is competent to execute a specification. The specification is where product quality is decided, and that is your call.

The decisions that determine whether your product is good:

• Standardisation, which marker, what percentage, measured how
• Identity testing on botanicals
• Heavy metals on every batch, with numerical results
• Pesticide residues, for agricultural material
• Aflatoxins, for susceptible materials
• Assay of the active
• Dose, matching what the research used, rather than what hits a price point
• Capsule shell and excipient choices
• Packaging adequate for Indian humidity
• Shelf life supported by actual stability data

None of these is determined by GMP. All of them are determined by what you specify and are willing to pay for.

Which is the uncomfortable conclusion: a brand owner who asks only “are you GMP certified?” has outsourced the quality decision to a framework that does not make it.

Our own position

We hold the statutory certifications and we will show them, with scope and expiry. We also think leading with them is slightly misleading, which is why this article exists.

What we would rather be asked: what we test on every batch, what our identification methods are, what standardisation we are quoting, and whether you can see a recent COA.

What we volunteer: heavy metals batch-wise on herbal products, identity testing on botanicals where substitution is documented, and the standardisation percentage on the quotation rather than after it.

And what GMP does not protect you from, which we will say plainly: we can manufacture a weak specification flawlessly. If you ask us to hit a price point by reducing a standardisation, and we agree, the resulting product will be GMP-compliant and will not be good. That decision is yours, and the certificate will not record it.

The short version

1. GMP governs how a product is made, not what is in it. Quality is built into the process rather than tested in at the end, a genuinely important idea.
2. It says nothing about your specification. A weak formula and a strong one can both be made under perfect GMP, with identical certificates.
3. “GMP certified” and “heavy metals tested every batch” are separate questions. Ask the second one.
4. It does not verify botanical identity unless identification is properly specified, and species substitution is documented in Indian herbal supply.
5. Check the certificate’s expiry and scope, not the logo on the website.
6. Schedule T GMP, FSSAI, WHO-GMP, ISO 9001, ISO 22000, NABL answer different questions. More logos is not a hierarchy.
7. NABL is for laboratories, not manufacturing.
8. Ask whether the licence is in their name and where the plant is. Some entities presenting as manufacturers are trading.
9. Ask to visit. Forty minutes in a plant beats any certificate.
10. The quality decisions are in the specification, and they are yours, standardisation, identity testing, heavy metals, dose.

More detail: choosing a contract manufacturer. Related: how to read a certificate of analysis and how to read a manufacturer’s quotation.