NTA Level 5 • Semester 2 • PST05207

GMP Documentations Requirements

Quality Assurance of Pharmaceutical Products • Source Session/Topic 5

Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability.

Session 5: GMP Documentations Requirements

Total Session Time: 120 minutes

Prerequisites

None

Learning Tasks

By the end of this session students are expected to be able to:

• Define documentation terms

• List good documentation practices

• Explain importance of Good Documentation

• Explain what constitutes Good Documentation

• Explain GMP documentation requirements

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Pointer

• LCD projector and computer

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

2 15 minutes Presentation Definition of Documentation Terms

25 minutes Presentation

3 Good Documentation Practices

Buzzing

4 15 minutes Presentation Importance of Good Documentation

5 15 minutes Presentation Constituents of Good Documentation

35 minutes GMP Documentation Requirements

6 Presentation

7 05 minutes Presentation Key points

8 05 minutes Presentation Evaluation

PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Documentation Terms (15minutes)

Batch (or lot): A defined quantity of starting material, packaging material, or product

processed in a single process or series of processes so that it is expected to be homogeneous.

It may sometimes be necessary to divide a batch into a number of sub-batches, which are

later brought together to form a final homogeneous batch. In the case

of terminal sterilization, the batch size is determined by the capacity of the autoclave. In

continuous manufacture, the batch must correspond to a defined fraction of the production,

characterized by its intended homogeneity. The batch size can be defined either as a fixed

quantity or as the amount produced in a fixed time interval.

“Manufacturing” includes all operations of receipt of materials, production, packaging,

repackaging, labelling, relabeling, quality control, release, storage and distribution of APIs

and the related controls

Master Formula: A document or set of documents specifying the starting materials with

their quantities and the packaging materials, together with a description of the procedures and

precautions required to produce a specified quantity of a finished product as well as the

processing instructions, including the in-process controls.

Master Record: A document or set of documents that serve as a basis for the batch

documentation (blank batch record).

ALCOA+ A commonly used acronym for „Attributable, Legible, Contemporaneous, Original

and Accurate‟ which puts additional emphasis on the attributes being „Complete, Consistent,

Enduring and Available‟– qualities which are implicit in the basic ALCOA principles.

Backup: A backup means a copy of one or more electronic files created as an alternative in

case the original data or system are lost or become unusable.

Computerized System: A computerized system can create, modify, maintain, archive,

retrieve or transmit electronic records. A computerized system consists of hardware, software

and network components which together fulfill certain functionalities. They can also be

defined as a logical entity, partially or entirely controlled by computer but may also include

some equipment, utilities, sensors and actuators along with the governing procedures.

Examples of such a system are Building Management System (BMS), Automated

Manufacturing/Laboratory System, Document Management System,

PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

Criterion Meaning

Attributable Attributable‟ means information is captured in the record such that it is

uniquely identified as executed by the originator of the data (e.g., a

person and/or a computer system).

Legible The terms „legible‟, „traceable‟ and „permanent‟ refer to the requirements

that data are readable, understandable and allow a clear picture of the

sequencing of steps or events in the record

Contemporaneous is the process of documentation (on paper or electronically)

at the time of the occurrence of an activity

Original Original‟ data includes the first capture or capture at source of data or

information and all subsequent data required to fully reconstruct the

conduct of the GxP activity

Accurate Accurate‟ means that data are correct, truthful, valid and reliable.

complete „Complete‟ means that all data from analysis, including any data

generated before a problem is observed, data generated after repeating

part or all of the work, or re-analysis performed on the sample are

contained in the data record

Consistent „ means that all elements of the analysis, such as the sequence of

events, follow on and data files are date-stamped (all processes) and time

stamped (when using a hybrid or electronic system) in the expected order

and such data are contained in the record.

Enduring Enduring‟ means that all data have been recorded on authorized media

which can be preserved for a period of time, e.g., laboratory notebooks,

numbered worksheets, for which there is accountability, or electronic

media. Data recorded on scrap paper or any other media which can be

discarded later, e.g., backs of envelopes, laboratory coat sleeves or

Post‑It notes, etc. are not considered enduring.

Available Available‟ means that the complete collection of records can be accessed

or retrieved for review and audit or inspection over the lifetime of the

record

PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

STEP 3: Good Documentation Practices (GDocP) (25 minutes)

Activity: Buzzing (5minutes)

ASK students to pair up and buzz on the following questions for 5 minutes

• What is a good documentation practice?

ALLOW few pairs to respond and let other pairs add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

The equipments used in facility based pharmaceutical preparation

Good documentation practice is an essential part of the quality assurance and such, related

to all aspects of GMP” this definition is based on WHO.

Principle

Good documentation constitutes an essential part of the quality assurance system. Clearly

Written documentation prevents errors from spoken communication and permits tracing of

Batch history. Specifications, Manufacturing Formulae and instructions, procedures, and

Records must be free from errors and available in writing. The legibility of documents is of

Paramount importance. Instructions must be in the imperative – Go, Do, Stop Mix, Blend,

Wash, etc…… Look for short sentences. Long sentences do not allow the reader time to grasp

messages. A florid, roseate style over endowed with polysyllabic phraseology confuses the

reader.

Good documentation practices include the following;

• Records should be completed at time of activity or when any action is taken

• Superseded documents should be retained for a specific period of time

• Records should be retained for at least one year after the expiry date of the finished product

• Concise, legible, accurate and traceable

• Picture is worth a thousand words

• Clear examples

• Don‟t assume knowledge.

Purpose of Documentations

• Defines specifications and procedures for all materials and methods of manufacture and

control

• Ensures all personnel know what to do and when to do it

• Ensure that authorized persons have all information necessary for release of product

PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

• Ensures documented evidence, traceability, provide records and audit trail for

investigation

• Ensures availability of data for validation, review and statistical analysis.

STEP 4: Importance of Good Documentation (15 minutes)

Good documentation is an essential part of GMP because:

• An essential part of the quality assurance system and should exist for all aspects of GMP

(reference: WHO GMP,Volume 2)

• Correct, complete, current, and consistent information effectively meet customer and

stakeholder' requirements

• Helps to reduce observations raised on inadequate documentation practices

• Simplify Communication.

• minimizes Costs and losses

• Audit trail. In incase for easy retrieval of any matter arise

STEP 5: Constituents of Good Documentation (15minutes)

Good documentation constitutes the following:

• Approve, review and update documents

• Changes & current revision status of documents identified

• Relevant versions of applicable documents available at points of use

• Documents remain legible and readily identifiable

• Documents of external origin identified and their distribution controlled

• Prevent unintended use of obsolete documents, and archiving

STEP 6: GMP Documentation Requirements (35 minutes)

The general requirements of GDocP as in accordance to GMP of Pharmaceutical

manufacturing are explained below as follows;

• Documents should be designed, prepared, reviewed and distributed with care. They

should comply with the relevant parts of the manufacturing and marketing authorizations.

• Documents should be approved, signed and dated by the appropriate responsible persons.

No document should be changed without authorization and approval.

• Documents should have unambiguous contents: the title, nature and purpose should be

clearly stated. They should be laid out in an orderly fashion and be easy to check.

Reproduced documents should be clear and legible. The reproduction of working

documents from master documents must not allow any error to be introduced through the

reproduction process.

• Documents should be regularly reviewed and kept up to date. When a document has been

revised, a system should exist to prevent inadvertent use of the superseded version.

Superseded documents should be retained for a specific period of time.

• Where documents require the entry of data, these entries should be clear, legible and

indelible. Sufficient space should be provided for such entries.

PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

• Any alteration made to a document should be signed and dated; the alteration should

permit the reading of the original information. Where appropriate, the reason for the

alteration should be recorded.

• Records should be made or completed when any action is taken and in such a way that all

significant activities concerning the manufacture of pharmaceutical products are

traceable. Records should be retained for at least one year after the expiry date of the

finished product.

• Specifications describe in detail the requirements with which the products or materials

used or obtained during manufacture have to conform. They serve as a basis for quality

evaluation.

• Manufacturing Formulae, Processing and Packaging Instructions state all the starting

materials used and lay down all processing and packaging operations.

• Procedures give directions for performing certain operations e.g. cleaning, clothing,

environmental control, sampling, testing, and equipment operations.

• Data may be recorded by electronic data processing systems, photographic or other

reliable means, but detailed procedures relating to the system in use should be available

and the accuracy of the records should be checked. If documentation is handled by

electronic data processing methods, only authorized persons should be able to enter or

modify data in the computer and there should be a record of changes and deletions; access

should be restricted by passwords or other means and the result of entry of critical data

should be independently checked. Batch records electronically stored should be protected

by back-up transfer on magnetic tape, microfilm, paper or other means. It is particularly

important that the data are readily available throughout the period of retention.

STEP 7: Key Points (5 minutes)

• Master Record: A document or set of documents that serve as a basis for the batch

documentation (blank batch record).

• Master Formula: A document or set of documents specifying the starting materials with

their quantities and the packaging materials, together with a description of the procedures

and precautions required to produce a specified quantity of a finished product as well as

the processing instructions, including the in-process controls.

• Labels are required for all containers, equipment and premises.

STEP 8: Evaluation (5 minutes)

• What is GDocP?

• What is difference between master formula and master record?

PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

References

Signore, A. A., & Jacobs, T. (2017). Good design practices for GMP pharmaceutical

facilities. Boca Raton, Fl.: CRC Press.

Lund, W. (2009). The pharmaceutical codex: Principles and practice of pharmaceutics. New

Delhi: CBS.

Aulton, M. E., & Taylor, K. (2018). Aulton s pharmaceutics: The design and manufacture of

medicines. Edinburgh: Elsevier.

Gad, S. C. (2008). Pharmaceutical manufacturing handbook production and processes.

Hoboken, NJ: Wiley-Interscience.

Rawlins E.A, Editor: 1977 Bentley’s Textbook of Pharmaceutics, 8th Ed. Baillie're Tindall.

London

PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

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