Documentation in Pharmaceutical Industry

1. - Hasan Hussain

2. o Distribution records include a wide range of
documentation such as
1. Invoices
2. Bills of lading
3. Customers receipt
4. Internal warehouse storage and inventory
records.
o The primary purpose of this section is to ensure
that adequate data is available so that recall can be
carried out.

3.  Written instructions and records should be
available.
 Procedures should be established and maintained.
 Documents should be designed, reviewed and
distributed with care.
 The title, nature and purpose of each document
should be clearly stated.
 The content of the document should be clear and
unambiguous. Document should be laid out in an
orderly fashion and be easy to check.
 All documents should be completed, approved and
signed and dated by an authorized person.

4.  There should be compliance with national legislative
requirements with regard to the nature, content and
retention of documentation, relating to the distribution of
the pharmaceutical product.
 The distributor must establish and maintain procedures for
identification, collection, indexing, storage, maintenance,
disposal of and access to all applicable documents.
 All documents should be readily retrievable, stored and
retained using facilities.
 Documents should be reviewed regularly and kept upto date
 Mechanism should exist to allow transfer of information.
 Records should be kept and be readily available upon
request.
 Where the records are generated and kept in electronic
media, their backup should be available to prevent data
loss.

5.  Modern solid oral dosage forms are expected to be
of high quality and exhibit reliable performance
characteristics.
 This is achieved by careful selection and quality
control of various ingredients and a well defined
manufacturing process, giving careful thought to
different variables that may influence product
appearance, potency, stability and dissolution.
 In vitro testing to characterize the potency and
release rate of the active ingredients in solid
dosage forms is based on the monographs in
USP/NF.

6.  Following oral administration of a solid oral
dosage form, the critical elements of drug
absorption are
 Disintegration, dissolution and solubalization
 Permeability across the membranes of GIT.

7.  Factors related to drug substance
 Solubility of the drug substance
 Polymorphism
 Salt factor and pH of the diffusion layer
 Surface area and particle size
 Formulation factors
 Manufacturing process factors
 Apparatus

8.  Scale up and post approval changes is a regulation
which facilitates the changes in the production of a
dosage form even after its approval for marketing by
FDA.
 Need of SUPAC
1. Information available regarding polymorphism,
solubility, etc., is little at the development stage.
2. The changes in the manufacturing process may further
lead to changes in the purity profile of the drug which
may lead to batch failure.
3. Scale up problems may arise after approval of the
product due to technological needs or other reasons.

9.  Advantages of SUPAC
1. SUPAC places the industry on a responsible
position in its development efforts.
2. The cost of producing new drugs and marketing
are high. Therefore, existing drugs are looked at
for development. SUPAC encourages the
industries in order to make the production
commercially viable.
3. The time required for approval of a new drug by
FDA is long. SUPAC guidelines helps in prolonging
the existing drug product life cycle by
appropriately incorporating improvements.
4. SUPAC reduces the burden of approval by FDA.

10. Level Definition
1. Changes that are unlikely to have any
detectable impact on formulation quality and
performances
2. Changes that could have a significant impact
on formulation quality and performances.
3. Changes that are likely to have a significant
impact on formulation quality and
performances.

11. Thank you