Oral Solid Dosage Manufacturing: Records to Ask For at Each Step

Oral solid dosage (OSD) manufacturing is the production of swallowed solid medicines, mainly tablets and capsules, from an active pharmaceutical ingredient (API, the component that produces the therapeutic effect) and excipients (the non-active materials that give the dose its bulk, flow, binding, disintegration and coating). Tablets and capsules account for 74.1% of the generic-drug (ANDA) listings in the openFDA National Drug Code directory as of 27 October 2026.

We counted listings in the openFDA National Drug Code (NDC) directory with marketing category ANDA (abbreviated new drug application, the US route for generic drugs), grouped by dosage-form term, on 27 October 2026. There were 50,955 listings.

These count listings, not unique drugs. The coated and release rows do not overlap, so at least 31% of listings (15,838 of 50,955) carry a coating or release-modifying term, counting only the exact terms in the table. Other coating terms in the same data, such as sugar-coated tablets and coated pellets, are not counted. Those products need extra steps and extra checks beyond a plain tablet or capsule.

Seven steps turn raw materials into a finished tablet or capsule: dispensing, blending, granulating (when needed), compressing or filling, coating (when needed), testing, and packaging. Each step hands a defined output to the next, and each leaves a record.

Impurities, dissolution failures and foreign matter or mix-ups cause most tablet and capsule recalls, not potency.

How we counted: we pulled openFDA drug enforcement records reported between 1 January 2023 and 27 October 2026 whose product description contained "tablet", "tablets", "capsule" or "capsules". That took four queries: tablet, tablets, capsule and capsules, each paged until exhausted. After removing duplicate records, that gave 968 product records in 481 distinct recall events (de-duplicated by event ID).

The labeling is our own classification, not FDA's. We labeled each event from the reason-for-recall text of the first product record collected for that event. We matched these keywords, not case-sensitive, in this order, and the first match won:

• Dissolution: "dissolution".
• Impurity, nitrosamine or degradant: "nitrosamine", "NDMA", "NDEA", "impurit", "degradat".
• Potency or content uniformity: "content uniformity", "subpotent", "sub-potent", "superpotent", "super-potent", "potency", "assay".
• Microbial: "microb", "bacteri", "yeast", "mold", "burkholderia".
• Stability or out-of-specification: "stability", "out of spec", "OOS", "failed".
• Labeling or packaging: "label", "packag", "carton", "blister", "bottle", "child-resistant".
• CGMP: "cgmp", "gmp". CGMP means current good manufacturing practice, FDA's manufacturing quality rules.

Events matching none of these are "Other reasons", the residual group. Percentages are shares of 481.

Read the shares as a rough ranking, not as failure rates: they count recall events, not batches made, openFDA labels its data unvalidated, and keyword matching can misfile an event, for example a "blister packs not properly sealed" reason lands under packaging even though it could be read another way.

Nitrosamines are a class of impurity for which FDA sets acceptable intake limits, and FDA's Control of Nitrosamine Impurities in Human Drugs guidance was revised in September 2024. As of October 2026, the revised guidance expects manufacturers to have completed risk assessments and confirmatory testing; the 1 August 2025 date for confirmatory testing for nitrosamine drug substance-related impurities (NDSRIs) has passed. Our page on nitrosamine impurities turns intake limits into specifications.

A buyer should ask for nine records, one for each stage of production, and judge each against a stated pass condition. The recall data suggests dissolution, impurity and line-clearance records deserve the closest look (our inference). The sheet below is our recommendation. It applies to any OSD manufacturer; we confirm which of these records are available for your product during the feasibility review.

The nine checkpoints cover the seven production steps above, with testing shown as dissolution and release testing, plus impurity control and batch release.

For checkpoint 6, dissolution testing is the test that measures how fast the active ingredient leaves the dosage form. It was the second most common recall category above.

FDA regulations require the in-process controls and quality review (21 CFR 211.110 and 211.192). FDA's process validation guidance, which is non-binding, sets out the expected approach to validation. The regulations sit in 21 CFR, Title 21 of the Code of Federal Regulations (the US drug regulations), and apply to drug products for the US market.

• 21 CFR 211.100 requires written procedures for production and process control.
• 21 CFR 211.110 requires written in-process control procedures. Its examples include "tablet or capsule weight variation", "disintegration time", "adequacy of mixing to assure uniformity and homogeneity" and "dissolution time and rate". In-process specifications must be consistent with the finished product's specifications.
• 21 CFR 211.192 requires that production and control records, including packaging and labeling, be reviewed and approved by the quality control unit. Unexplained discrepancies and specification failures must be investigated, with the conclusions written down.
• FDA's Process Validation guidance (January 2011), which is non-binding, defines process validation as collecting and evaluating data that establish scientific evidence a process "is capable of consistently delivering quality product". It describes three stages: process design, process qualification and continued process verification. It expects process performance qualification (PPQ, commercial-scale batches that confirm the process performs as expected) to be completed before commercial distribution.

FDA's inspection guide for oral solid dosage forms, dated January 1994 and so older than the 2011 process validation guidance, lists eight areas an investigator evaluates: biobatch relationship (the link to the batch used in the studies that support approval), raw materials, manufacturing procedures and equipment, granulation and mix analysis, in-process controls, validated test methods, investigations of failures, and site review. Our sheet touches five of them: raw materials, granulation and mix analysis, in-process controls, validated test methods and investigations of failures. The mapping is our own.

We are a technology-driven CDMO focused on oral dosage forms, from product development through commercial manufacturing. As of October 2026, our regulatory standing is with Uttarakhand drug control. Tablets and capsules are among the finished-dose categories on our products page. We serve generic-drug manufacturers, contract formulators and pharmaceutical distributors.

Our buying route runs in this order: inquiry, feasibility review, commercial quotation, development or technical transfer, production and quality control, packaging, and dispatch. Before choosing any contract manufacturer, our quote and vetting pack for third-party manufacturing covers the commercial side.

In your inquiry, we recommend you include the product, strength, dosage form, batch size, target market, specifications, packaging format and the documents you need. Those details let a manufacturer judge feasibility properly.

To begin, use our contact form, call or WhatsApp +91 9899783330, or email sunil@aarisepharma.com. We send a commercial quotation after the feasibility review.