# Quality & Project Controls for Oral Film Manufacturing | StripWorks

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Description: How StripWorks controls oral film quality: what the specification, batch record, certificate of analysis, Lot Release Packet and change-control record contain for every lot, with 21 CFR Part 111 as the reference.

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QUALITY · DOCUMENTATION · CHANGE CONTROL

# The records behind every lot, and what is in them.

StripWorks holds no certifications yet and does not claim any. It runs every lot against a written specification, keeps a full batch record, tests through a third-party lab and hands over a Lot Release Packet. This page lists what each contains, using 21 CFR Part 111, the supplement GMP rule, as the reference buyers and auditors expect, not as a StripWorks status.

[Start a project brief](https://stripworks.com/#start)[hello@stripworks.com](mailto:hello@stripworks.com)

ANSWER IN BRIEF

How StripWorks controls oral film quality: what the specification, batch record, certificate of analysis, Lot Release Packet and change-control record contain for every lot, with 21 CFR Part 111 as the reference.

![Analytical laboratory equipment used to illustrate project-specific testing planning](https://stripworks.com/assets/analytical-lab.jpg)

Analytical laboratory equipment used to illustrate project-specific testing planning

## The approved brief

The controlled path starts with the brief: formula version, target amount of active per strip, serving, intended market, claims under consideration, sensory criteria, strip size, package, quantity, timing and who on each side signs off. Once approved, the brief is the reference for everything after it. A request that changes it is written up as a change, not handled in a chat thread.

## Component and supplier records

For each ingredient StripWorks records identity, form, supplier, lot number, supplier COA and storage conditions, and sets a component specification for identity, purity, strength, composition and contaminant limits, as 21 CFR 111.70 describes. A supplier certificate alone does not qualify a material; it is checked against the specification for the actual product.

## Product and packaging specifications

The product specification gives each attribute a method, sampling plan and acceptance range: appearance, dimensions and weight, moisture or water activity, seal integrity and coding, potency, content uniformity where dose-critical, and micro. Packaging gets the same: sachet material, carton count, artwork version, case pack.

## Master and batch records

The master manufacturing record (21 CFR 111 Subpart H) fixes formula, batch size, instructions, in-process checks and packaging. Each lot's batch production record (Subpart I) lists lot number, equipment, actual lot and weight of every component, in-process results, yield, label reconciliation, deviations, and the quality review signature. Each is kept for audit.

## Certificate of analysis and Lot Release Packet

A finished-product COA lists product, lot number, manufacture date, each test with method, limit and result, the lab and the approver. Third-party tests run through ILS Lab. Each lot's Lot Release Packet holds that COA, a certificate of conformance stating the lot met specification, the lot ID, reconciliation, packaging IDs and the third-party results.

## Change control

A change-control record captures what is changing (formula, supplier, package, artwork, method, batch size or process), why, who asked, its effect on specification, stability and labeling, required testing or re-pilot, the approver and the first affected lot. Reorders are checked against open changes before materials are bought.

## Certifications and claims

StripWorks holds no certifications and says so. Retailers that require particular certifications should ask before a project starts; StripWorks will say whether its records and third-party testing meet the requirement or not. Website text never stands in for the specification, batch record or COA of a given lot, and nothing on this site is a health or disease claim about any product.

**500** BOX PILOT PATH

**20 / 30** STRIPS PER BOX

**GLOBAL** MARKET SERVED

## Continue with verified facts.

## Primary sources

- [21 CFR Part 111, Current Good Manufacturing Practice for dietary supplements (eCFR)](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111)

- [21 CFR 111.70, specifications for components, in-process and finished product](https://www.ecfr.gov/current/title-21/section-111.70)

- [21 CFR 111 Subpart H, master manufacturing record](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111/subpart-H)

- [21 CFR 111 Subpart I, batch production record](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111/subpart-I)

- [21 CFR 111 Subpart P, records and recordkeeping](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111/subpart-P)

[Complete manufacturing capabilities](https://stripworks.com/oral-film-manufacturing-capabilities)[Quality and project controls](https://stripworks.com/quality-and-project-controls)[Manufacturer buyer checklist](https://stripworks.com/insights/choosing-an-oral-film-manufacturer)[Send a project brief](https://stripworks.com/#start)