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Understanding the problems in pharmaceutical procurement with special reference to active pharmaceutical ingredients and excipients

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Abstract

Procurement of raw materials, key intermediates and excipients for the preparation of finished pharmaceutical preparation is considered to be complex process which involve multiple channels and require skilled personnel and proper validation. This review attempts, in relatively brief compass to provide an account of the problems that arise while procurement of active pharmaceutical ingredient (API) and excipients in pharmaceutical industry. This review has been structured with specified as well as generalized problems raised up during procurement of API and other material in pharmaceutical industry. Lack of proper regulatory requirements and unbiased market information with the absence of a comprehensive procurement policy is the major factor which creates complications while procurement. Besides these, lack of properly designed user requirement specifications (URS) which ultimately affect quality and delivery of quoted material. An 8-Question-based approach has been proposed to design URS, other approaches for material procurement and supplier qualification have been discussed, and a vendor certification procedure is presented.

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Abbreviations

IP:

Indian Pharmacopoeia

USP:

United States Pharmacopeia

BP:

British Pharmacopoeia

JP:

Japanese Pharmacopoeia

API:

Active pharmaceutical ingredient

URS:

User requirement specifications

KSM:

Key starting materials

CAS:

Chemical abstract service no.

IUPAC:

International Union of Pure and Applied Chemistry

EP:

European Pharmacopoeia

GMP:

Good manufacturing practices

GLP:

Good laboratory practices

ECPPA:

Ethoxy carbonyl phenyl propyl alanine

RP:

Reaction product

MAP:

Michael addition product

DMF:

Drug master file

CMC:

Chemistry, manufacturing and control

CTD:

Common technical document

USFDA:

United States Food and Drug Administration

NF:

National formulary

QUEST:

Question, understand, evaluate, site audit, and track

IPEA:

International Pharmaceutical Excipients Auditing

EMA:

Economically motivated adulteration

GDP:

Good distribution practices

GPP:

Good pharmaceutical procurement

IPC:

Interagency Pharmaceutical Coordination Group

UNICEF:

United Nations Children’s Fund

UNFPA:

United Nations Population Fund

FPP:

Finished pharmaceutical product

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Authors and Affiliations

  1. Incompatibility Study Division & Analytical Laboratory (ISFAL), Department of Quality Assurance, ISF College of Pharmacy, Moga, 142001, India

    Zauwad Alam, Sukhbir Kaur & Pawan Kumar Porwal

  2. Amity Institute of Pharmacy (AIP), Amity University Madhya Pradesh, Gwalior, 472020, India

    Pawan Kumar Porwal

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  1. Zauwad Alam
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  2. Sukhbir Kaur
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Correspondence to Pawan Kumar Porwal.

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Alam, Z., Kaur, S. & Porwal, P.K. Understanding the problems in pharmaceutical procurement with special reference to active pharmaceutical ingredients and excipients. Accred Qual Assur 23, 319–328 (2018). https://doi.org/10.1007/s00769-018-1344-6

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