Lot traceability
Lot traceability is the ability to connect a quantity of material, through its batch or lot number, to the records of how it was produced, tested and distributed. ICH Q7 defines a batch number, or lot number, as a unique combination of numbers, letters and/or symbols that identifies a batch or lot and from which the production and distribution history can be determined.[1]
What is a batch or lot?
ICH Q7 defines a batch, or lot, as a specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In continuous production, a batch may correspond to a defined fraction of the production, and the batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.[1]
U.S. labeling rules for in vitro diagnostic products express the same link between a label and a history: 21 CFR 809.10(a)(9) calls for a lot or control number, identified as such, from which it is possible to determine the complete manufacturing history of the product.[2]
Which records does a batch number connect?
ICH Q7 states that batch production records should be prepared for each intermediate and active pharmaceutical ingredient, should include complete information relating to the production and control of each batch, and should be numbered with a unique batch or identification number, dated and signed when issued.[1]
The items ICH Q7 lists for documenting each significant production step include the batch numbers of raw materials, intermediates or reprocessed materials used, in-process and laboratory test results, any deviation noted, and the results of release testing.[1]
For incoming materials, ICH Q7 states that each container or grouping of containers should be assigned and identified with a distinctive code, batch or receipt number, and that this number should be used in recording the disposition of each batch.[1]
ICH Q7 also states that when a batch fails to meet specifications or a critical deviation occurs, the investigation should extend to other batches that may have been associated with the specific failure or deviation.[1]
How is the distribution of a lot traced?
ICH Q7 states that a system should be in place by which the distribution of each batch of intermediate or active pharmaceutical ingredient can be readily determined to permit its recall.[1]
Section 17.2 of ICH Q7 states that agents, brokers, traders, distributors, repackers and relabelers should maintain complete traceability of the materials they distribute. The documents it lists include the identity and address of the original manufacturer, procurement records, bills of lading, receipt documents, the name or designation of the material, the manufacturer's batch number, transportation and distribution records, all authentic certificates of analysis including those of the original manufacturer, and the retest or expiry date.[1]
ICH Q7 states that production, control and distribution records should be retained for at least 1 year after the expiry date of the batch, and, for active pharmaceutical ingredients with retest dates, for at least 3 years after the batch is completely distributed.[1]
How does a certificate of analysis connect to the original lot?
Section 11.4 of ICH Q7 lists the batch number among the items a certificate of analysis should carry, and states that certificates should show the name, address and telephone number of the original manufacturer. Where the analysis has been carried out by a repacker or reprocessor, the certificate should show that party's name, address and telephone number and reference the name of the original manufacturer.[1]
If new certificates are issued by or on behalf of repackers, reprocessors, agents or brokers, ICH Q7 states that they should show the name, address and telephone number of the laboratory that performed the analysis, and should contain a reference to the name and address of the original manufacturer and to the original batch certificate, a copy of which should be attached.[1]
Certificates of analysis are available on request. Include the lot code. Requests go to info@pepgenex.com.
What does ICH Q7 say about repackaging and relabeling?
ICH Q7 states that repackaging, relabeling and holding of active pharmaceutical ingredients and intermediates should be performed under appropriate good manufacturing practice controls to avoid mix-ups and loss of identity or purity.[1]
It also states that stability studies to justify assigned expiration or retest dates should be conducted if the material is repackaged in a different type of container than that used by the original manufacturer.[1]
Limitations
A lot number connects material to records; it does not by itself show what those records contain or that they are complete. ICH Q7 describes what batch, laboratory and distribution records should hold, not what any particular record holds.[1]
A result on a certificate applies to the batch it names. ICH Q7 defines a batch as a quantity expected to be homogeneous only within specified limits, and a result for one lot says nothing about another lot.[1]
This page describes what the cited documents say. It is not a statement that any PepGenex material has been manufactured, tested or released under any of them.
Compound profiles
Research peptide profiles in this library. What this page describes applies to peptide lots in general; none of these profiles reports a result of it for any lot.
References
- ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. U.S. FDA guidance for industry, September 2016. FDA docket FDA-1995-D-0288
- 21 CFR 809.10, Labeling for in vitro diagnostic products (2025 edition), paragraphs (a)(9) and (c)(2)(i)-(ii). 21 CFR 809.10